(178 days)
Not Found
No
The summary describes a standard ureteroscope system with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The focus is on visualization and basic image processing for diagnostic and therapeutic procedures.
Yes
The device description explicitly states that the RenaFlex Single-use Flexible Ureteroscope System provides "access for diagnostic and therapeutic applications, including urinary system biopsy and kidney stone treatment and removal."
Yes
The device "provides a means for direct visualization, diagnosis, and treatment of various diseases in the urinary tract and kidneys" and "receives, processes, and outputs images from the compatible Olympus endoscope for diagnostics, treatment, and observation," explicitly indicating diagnostic capabilities.
No
The device system includes a physical ureteroscope and a Video System Center, both of which are hardware components, in addition to the software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The RenaFlex™ Single-use Flexible Ureteroscope and the Video System Center are used to visualize and perform procedures within the urinary tract. This is an in vivo (within the living body) application.
- Intended Use: The intended use clearly states visualization and procedures within the urinary tract, not testing of samples taken from the body.
- Device Description: The description focuses on accessing anatomy, guiding accessories, and providing visualization for diagnosis and treatment directly within the body.
The device is an endoscopic system used for direct visualization and intervention within the urinary tract, which falls under the category of medical devices used in vivo, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RenaFlex™ Single-use Flexible Ureteroscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra. bladder, ureter, calvces and renal papillae) via transurethral or percutaneous access routes. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
The Video System Center for Single Use Endoscopes is intended to provide illumination and receive, process, and output images from the compatible Olympus endoscope for diagnostics, treatment, and observation.
Product codes
FGB
Device Description
The RenaFlex Single-use Flexible Ureteroscope System will provide visualization and access for diagnostic and therapeutic applications, including urinary system biopsy and kidney stone treatment and removal. The RenaFlex Single-use Flexible Ureteroscope and compatible Video System Center for Single-use Endoscopes provide a means for direct visualization, diagnosis, and treatment of various diseases in the urinary tract and kidneys. The ureteroscope component of the system is intended as a single-use device that works to access the anatomy and to guide accessory devices for diagnostic and therapeutic applications in the urinary tract and kidneys. The compatible Video System Center for Singleuse Endoscopes is a reusable software-driven device that provides illumination and receives, processes, and outputs images from the endoscope using field upgradable software for diagnosis, treatment, and observation.
Mentions image processing
Yes
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed for Shelf-life, Sterilization, Biocompatibility, and Electrical performance. Performance tests were conducted for Mechanical performance (e.g., Insertion Portion Width, Nuetral Angle, Maximum Angle of Deflection, Ureteroscopy Device Compatibility, Ureteral Access Sheath Compatibility, Working Channel Flow, Handle to Connector Tensile Strength, Overall Weight, Connector Cable Length, Working Length, Working Channel Integrity, Planarity, Lever Force, Minimum Instrument Channel Width/Tool Passage, Passive deflection, Shaft Stiffness, Shaft to Tip Tensile Strength, Guidewire Compatibility, Shaft to Handle Tensile Strength), Optical performance (e.g., Signal to Noise Ratio, Geometric Distortion Test, Depth of Brightness, Color Performance, Field of View, Video Image Latency, Resolution, Image Intensity Uniformity), and Human Factors (Formative and Summative Evaluations). All evaluation acceptance criteria were met for all tests. Clinical studies were not necessary for substantial equivalence determination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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March 25, 2024
Gyrus ACMI, Inc Andrea Curria Program Manager, Regulatory Affairs 9600 Louisiana Avenue North Brooklyn Park, Minnesota 55445
Re: K233275
Trade/Device Name: RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: February 27, 2024 Received: February 28, 2024
Dear Julie Acker:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard);
RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse);
Video System Center for Single-use Endoscopes (CV-S1)
Indications for Use (Describe)
The RenaFlex™ Single-use Flexible Ureteroscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra. bladder, ureter, calvces and renal papillae) via transurethral or percutaneous access routes. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
The Video System Center for Single Use Endoscopes is intended to provide illumination and receive, process, and output images from the compatible Olympus endoscope for diagnostics, treatment, and observation.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary General Information Manufacturer: Gyrus ACMI, Inc. 9600 Louisiana Avenue, North Brooklyn Park, MN 55445 USA Phone: 1-763-416-3000 Establishment Registration Number: 3011050570 510(k) Submitter: Gyrus ACMI, Inc. 800 West Park Road Westborough, MA 01581 Establishment Registration Number: 3003790304 Contact Person: Andrea Curria Program Manager, Regulatory Affairs Email: andrea.curria@olympus.com Phone: (508) 262-8682 Date Prepared: February 26, 2024 Device Description Classification Name: Endoscope and Accessories Regulation Number: 8876.1500 Product Code: FGB Regulatory Class: Class 2 Review Panel: Gastroenterology/DHT3A Trade Name: RenaFlex™ Single-use Flexible Ureteroscope System (RenaFlex Single-use Flexible Ureteroscopes and Video System Center for Single-use Endoscopes) Generic/Common Name: Ureteroscope and Accessories/Flexible/Rigid SUURF-V, SUURF- VR and CV-S1 Model Number: Predicate Device
Boston Scientific, Inc. LithoVue System K153049
Product Description
The RenaFlex Single-use Flexible Ureteroscope System will provide visualization and access for diagnostic and therapeutic applications, including urinary system biopsy and kidney stone treatment and removal. The RenaFlex Single-use Flexible Ureteroscope and compatible Video System Center for Single-use Endoscopes provide a means for direct visualization, diagnosis, and treatment of various
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diseases in the urinary tract and kidneys. The ureteroscope component of the system is intended as a single-use device that works to access the anatomy and to guide accessory devices for diagnostic and therapeutic applications in the urinary tract and kidneys. The compatible Video System Center for Singleuse Endoscopes is a reusable software-driven device that provides illumination and receives, processes, and outputs images from the endoscope using field upgradable software for diagnosis, treatment, and observation.
Technological Characteristics
The Renaflex Single Use Ureteroscope System provides direct endoscopic access and visualization of the urinary system. For diseases of the urinary system, the ureteroscope enables passage of accessory devices to aid in diagnostic and therapeutic success.
The Renaflex Single Use Ureteroscope System has the same technological characteristics and fundamental design as the predicate device. The Renaflex Single Use Ureteroscope System and the predicate device are designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the urinary tract.
Material
Patient contacting materials is nearly identical to the predicate device and were subject to biocompatibility evaluation against ISO 10993 for a surface-mucosal membrane type contact with limited contact duration (