(263 days)
No
The summary describes a mechanical device for delivering therapeutic agents and solutions, with no mention of AI/ML, image processing for analysis, or software changes that would suggest AI/ML capabilities.
Yes
The device is intended for "direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract," indicating its use in administering therapies.
No
The "Intended Use / Indications for Use" states that the device is "intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract." This indicates a therapeutic, not diagnostic, purpose.
No
The device description explicitly details hardware components including a hand-held, battery-operated endoscope, a reusable handle, a disposable cannula with an injection needle, and a video camera. While software is mentioned, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope." This describes a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a cystoscope with an injection needle. This is a surgical/interventional tool used for direct access and delivery within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device is used for delivering substances, not for testing them or the patient's condition based on a sample.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
FAJ, FBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image transmitted from a video camera at the tip of the cannula to a video monitor on the handle
Anatomical Site
Bladder and lower urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals and physician offices
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 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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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) |
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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 |