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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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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.
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.
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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 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
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# 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) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size: 1em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 1em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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K182876
# SECTION 5. 510(k) Summary
## General Information
| Submitter | UroViu Corporation |
|-------------------------|-------------------------------------------------------------------------------------|
| Address | 5337 – 145th Place SE<br>Bellevue, WA 98006 |
| FDA Registration Number | 3007498664 |
| Correspondence Person | Thomas Lawson, PhD<br>Vice President, Clinical & Regulatory Affairs<br>UroViu Corp. |
| Contact Information | Email: thom@uroviu.com<br>Phone: 510-206-1794 |
| Date Prepared | 1 July 2019 |
# Proposed Device
| Trade Name | Uro-N Cystoscope |
|----------------------------------------------|--------------------------------------------|
| Common Name | Uro-N cystoscope |
| Regulation Number and<br>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<br>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<br>system with<br>injection cannula<br>(UroViu Corp.)<br><br>(This Submission) | Williams<br>Cystoscopic<br>Injection<br>Needle<br>(Cook Medical)<br><br>K171602 | Uro-V Cystoscope<br>with diagnostic<br>cannula<br>(UroViu Corp.)<br><br>K171500 |
| Indication for Use | The Uro-N<br>cystoscope is<br>indicated for<br>injection of | The Williams<br>Cystoscopic<br>Injection<br>Needle is | The Uro-V<br>cystoscope is<br>indicated for<br>diagnostic |
| | | | |
| | indicated for<br>injection of<br>therapeutic agents<br>in the bladder and<br>lower urinary tract<br>for neurogenic<br>bladder, overactive<br>bladder syndrome,<br>increased<br>frequency and<br>urgency of<br>urination, scarring<br>of the bladder<br>neck, and Hunner's<br>ulcer. | indicated for<br>injection of<br>therapeutic<br>agents in the<br>bladder and<br>lower urinary<br>tract. | cystoscopy of<br>symptomatic<br>voiding<br>dysfunction,<br>hematuria, bladder<br>tumor surveillance,<br>recurrent lower<br>urinary tract<br>infections, and<br>pelvic pain<br>syndromes. |
| Intended use | Directed injection<br>of therapeutic<br>agents and<br>solutions into<br>target areas of the<br>bladder and the<br>lower urinary tract<br>via a cystoscope | Directed<br>injection of<br>therapeutic<br>agents into the<br>urethra, bladder<br>neck, and<br>bladder wall via<br>a cystoscope | Endoscopic<br>diagnosis and<br>infusion of<br>irrigating fluid<br>within the bladder<br>and urethra |
| Route of Advancement | The cannula of the<br>cystoscope is<br>advanced to the<br>bladder via the<br>urethra, with the<br>injection needle<br>advanced to the<br>bladder via a<br>working channel of<br>the cystoscope | The injection<br>needle is<br>advanced to the<br>bladder via the<br>working<br>channel of a<br>cystoscope | The cannula of the<br>cystoscope is<br>advanced to the<br>bladder via the<br>urethra |
| Site of Use | Hospitals and<br>physician offices | Same | Same |
| Device Features | | | |
| Components of the<br>System | Reusable handle<br>with a video screen<br>that acts as an<br>endoscope<br>Attachable cannula<br>with an injection | Injection<br>Needle<br>with a hub | Reusable handle<br>with a video screen<br>that acts as an<br>endoscope<br>Attachable cannula<br>with a working |
| | needle, a working<br>channel along its | | channel along its<br>length and an |
| | length, and an<br>illumination source<br>and camera at its tip | | illumination source<br>and camera at its tip |
| Imaging Transmission | Image transmitted<br>from a video<br>camera at the tip of<br>the cannula to a<br>video monitor on<br>the handle | No imaging<br>component | Image transmitted<br>from a video<br>camera at the tip of<br>the cannula to a<br>video monitor on<br>the handle |
| Illumination Light<br>Source | LEDs | N/A | LEDs |
| LCD Monitor Display<br>Size | 3.5 inches<br>(diagonal) on the<br>handle | N/A | 3.5 inches<br>(diagonal) on the<br>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<br>Center Axis | 15 degrees | N/A | 30 degrees |
| Electrical Safety | Class I, Type CF,<br>defibrillation proof<br>IEC 60601-1 | N/A | Class I, Type CF,<br>defibrillation proof<br>IEC 60601-1 |
| Electromagnetic<br>compatibility | IEC 60601-1-2 | N/A | IEC 60601-1-2 |
| Software Level of<br>Concern | Moderate | N/A | Moderate |
| Sterilization method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Sterility Assurance<br>Level | 10-6 | Same | Same |
| Biocompatibility of<br>Materials | Meets ISO 10993<br>requirements | Same | Same |
| Operational<br>Characteristics | | | |
| Length of cannula | 269 mm | N/A | 254 mm |
| Working Channel Inner<br>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<br>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)<br><br>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)<br><br>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.
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{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.
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3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
