(304 days)
No reference predicates were used in this submission.
No
The summary describes a standard ureteroscope system for visualization and procedures, with no mention of AI, ML, image processing beyond basic camera function, or data sets for training/testing algorithms.
Yes
The device description states it enables the "delivery of therapeutic accessories" and the intended use indicates it can be used to perform "various diagnostic and therapeutic procedures."
Yes
The device is described as being used "to visualize organs, cavities and canals in the urinary tract" and to perform "various diagnostic and therapeutic procedures in the urinary tract." Visualization for the purpose of identifying conditions or abnormalities is a diagnostic function.
No
The device description explicitly states it is comprised of a single-use ureteroscope (hardware) and a multi-use video processing unit (hardware).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to visualize organs, cavities, and canals in the urinary tract and to perform diagnostic and therapeutic procedures within the body. This is an in vivo use, not in vitro (outside the body).
- Device Description: The device is a ureteroscope, which is an endoscopic instrument used to visualize and access the urinary tract. This is a surgical/procedural device, not a device used to test samples of bodily fluids or tissues in vitro.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside the body.
Therefore, the RenaNav Ureteroscope System is a medical device used for in vivo visualization and procedures, not an IVD.
N/A
Intended Use / Indications for Use
The ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Product codes
FGB
Device Description
The RenaNav Ureteroscope System is comprised of a single-use ureteroscope and a multi-use video processing unit (VPU). The RenaNav Single-Use Digital Flexible Ureteroscope is a sterile, single use device and is compatible with the multi-use System Video Processing Unit. The Ureteroscope is used by physicians to access, visualize, and perform procedures in the urinary tract.
The flexible shaft of the ureteroscope includes one working channel which enables the delivery of therapeutic accessories and irrigation/ contrast solutions to the distal tip and desired anatomical location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (urethra, bladder, ureter, calyces and renal papillae)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
All necessary performance testing has been conducted on the RenaNav Ureteroscope System to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests:
- . Biocompatibility testing per FDA Final Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2020)
- . Sterilization validation per ANSI/AAMI/ISO 11135
- Packaging validation per ANSI/AAMI/ISO 11607-1
- . Electrical Safety and electromagnetic (EMC) Testing per applicable requirements of IEC 60601-1, IEC 60601-1-2, & IEC 60601-2-18.
- Simulated use testing, including use with ancillary devices
- . Scope and VPU Dimensional verification, including proximal/distal OD, working length & ID, working channel length, curl diameter, umbilical cable length
- Deflection verifications .
- . Image testing, including illumination verification, Field of View and direction measurement, camera function, camera light ingress and glare
- HDMI compatibility .
- Image functionality and gain function
- Sheath compatibility
- Leak test ●
- Tensile tests ●
- Optics testing, including Resolution, ● Depth of Field, Field of View, Geometric distortion, Signal-to-Noise Ratio, Dynamic Range, Image intensity uniformity, color performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference predicates were used in this submission.
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 31, 2023
CenterPoint Systems, LLC Marybeth Gamber VP. Regulatory & Quality 3338 Parkway Blvd. West Valley City, UT 84119
Re: K223097
Trade/Device Name: RenaNav Ureteroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: June 29, 2023 Received: June 30, 2023
Dear Marybeth Gamber:
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,
Mark R. Kreitz -S
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223097
Device Name RenaNav Ureteroscope System
Indications for Use (Describe)
The ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
| 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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3
5 510(K) SUMMARY
5.1 Submitter
| Name | CenterPoint Systems LLC |
|---|---|
| Address | 3338 Parkway Blvd |
| West Valley City UT | |
| Phone | 877-848-0828 |
| Contact Person: | Marybeth Gamber, Vice President Regulatory Affairs & Quality Assurance |
| Date Prepared: | July 25, 2023 |
5.2 Device
| Name of Device: | RenaNav Ureteroscope System |
|---|---|
| Common or Usual Name | Ureteroscope System |
| Regulation Name: | Endoscope and Accessories |
| Regulatory Class: | Class II per 21 CFR 876.1500 |
| Product Code: | FGB |
Predicate Device 5.3
Predicate Name and 510(k) Number: LithoVue System, K153049
This predicate has not been subject to a design-related recall.
No reference predicates were used in this submission.
5.4 Device Description
The RenaNav Ureteroscope System is comprised of a single-use ureteroscope and a multi-use video processing unit (VPU). The RenaNav Single-Use Digital Flexible Ureteroscope is a sterile, single use device and is compatible with the multi-use System Video Processing Unit. The Ureteroscope is used by physicians to access, visualize, and perform procedures in the urinary tract.
The flexible shaft of the ureteroscope includes one working channel which enables the delivery of therapeutic accessories and irrigation/ contrast solutions to the distal tip and desired anatomical location.
4
ર્ ર ર્ Indications for Use
The ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
The indications for use statement is identical to the predicate device.
5.6 Comparison of Technological Characteristics with the Predicate Device
The Proposed Device and Predicate Device are similar in indications for use, intended use, technological characteristics, and principles of operation.
The differences between the Proposed Device and the Predicate Device are minor and raise no different questions of safety and effectiveness, thus it was concluded that the Proposed Device is substantially equivalent to the Predicate Device. In accordance with 21CFR807.92(a)(6) a summary of how the technological characteristics of the Proposed Device compares to the Predicate Device is provided below.
| Feature | RenaNav Single Use Digital
Flexible Ureteroscope (proposed
device) | Primary Predicate: LithoVue
Single Use Digital Flexible
Ureteroscope (K153049) | Same/Different
between
Proposed &
Predicate |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Intended
Use/Indicatio
ns for Use | The ureteroscope is intended to
be used to visualize organs,
cavities and canals in the
urinary tract (urethra, bladder,
ureter, calyces and renal
papillae) via transurethral or
percutaneous access routes. It
can also be used in conjunction
with endoscopic accessories to
perform various diagnostic and
therapeutic procedures in the
urinary tract. | The ureteroscope is intended
to be used to visualize organs,
cavities and canals in the
urinary tract (urethra, bladder,
ureter, calyces and renal
papillae) via transurethral or
percutaneous access routes. It
can also be used in
conjunction with endoscopic
accessories to perform various
diagnostic and therapeutic
procedures in the urinary
tract. | Same |
| Device Class | II | II | Same |
| Product Code | FGB | FGB | Same |
| Regulation
number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Duration of
use | Single-use, Transient | Single-use, Transient | Same |
| Insertion Site | Urethra or Percutaneous Access | Urethra or Percutaneous Access | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Prescription
Device | Yes | Yes | Same |
| Working
Channel | 3.6F | 3.6F | Same |
| Working
Length | 68cm | 68cm | Same |
5
| Feature | RenaNav Single Use Digital
Flexible Ureteroscope (proposed
device) | Primary Predicate: LithoVue
Single Use Digital Flexible
Ureteroscope (K153049) | Same/Different
between
Proposed &
Predicate |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Brightness
Control | Yes | Yes | Same |
| Illumination
Type | LED | LED | Same |
| Up/Down
Deflection | 270 degrees, both directions | 270 degrees, both directions | Same |
| Guidewire
Compatibility | Max outside diameter 0.97mm
(0.038") | Max outside diameter
0.97mm (0.038") | Same |
| Minimum
Bend Radius | 8mm | 8mm | Same |
| Materials/
Biocompatibili
ty | Standard medical device
materials
The biocompatibility tests
demonstrate that there are no
adverse biocompatibility risks
associated with use of this
material. All test results met
the requirements of ISO
10993-1. | Standard medical device
materials.
The biocompatibility tests
demonstrate that there are no
adverse biocompatibility risks
associated with use of this
material. All test results met
the requirements of ISO
10993-1. | Same |
| Features | Handle, Articulation Lever,
Umbilical Cable, Accessory
Access Port, Irrigation Port | Handle, Articulation Lever,
Umbilical Cable, Accessory
Access Port, Irrigation Port | Same |
| EMC Safety
Testing | Complies with applicable
clauses of IEC-60601 | Complies with applicable
clauses of IEC-60601 | Same |
The RenaNav Ureteroscope System is used for the same intended use in the same anatomical location using the same principles of operation as the predicate device. Therefore, the RenaNav Ureteroscope System can be considered substantially equivalent to the predicate device.
5.7 Performance Data
All necessary performance testing has been conducted on the RenaNav Ureteroscope System to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. The device passed the following tests:
- . Biocompatibility testing per FDA Final Guidance Document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (2020)
- . Sterilization validation per ANSI/AAMI/ISO 11135
- Packaging validation per ANSI/AAMI/ISO 11607-1
- . Electrical Safety and electromagnetic (EMC) Testing per applicable requirements of IEC 60601-1, IEC 60601-1-2, & IEC 60601-2-18.
- Simulated use testing, including use with ancillary devices
510(k) Summary
6
Traditional 510(k) Premarket Notification Submission: RenaNav Ureteroscope System
- . Scope and VPU Dimensional verification, including proximal/distal OD, working length & ID, working channel length, curl diameter, umbilical cable length
- Deflection verifications .
- . Image testing, including illumination verification, Field of View and direction measurement, camera function, camera light ingress and glare
- HDMI compatibility .
- Image functionality and gain function
- 5.8 Conclusions
- Sheath compatibility
- Leak test ●
- Tensile tests ●
- Optics testing, including Resolution, ● Depth of Field, Field of View, Geometric distortion, Signal-to-Noise Ratio, Dynamic Range, Image intensity uniformity, color performance.
Upon reviewing the information provided in this submission and comparing the intended use, principle of operation and overall technological characteristics, the RenaNav Ureteroscope System is substantially equivalent to existing legally marketed devices.