(224 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the performance studies focus on standard device functionalities and safety, not algorithmic performance.
No
The device is an ureteroscope system intended for visualization and access to perform procedures, enabling the use of accessories, but it does not directly provide a therapeutic effect itself.
No
The device is described as an instrument for accessing, visualizing, and performing procedures, and enabling delivery of accessories, rather than providing a medical diagnosis.
No
The device description explicitly states it consists of a single-use digital flexible ureteroscope (hardware) and a video processing unit (hardware), in addition to being software-controlled. This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided information, the URUS System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used by physicians to "access, visualize, and perform procedures in the urinary tract and the kidney." This describes a device used for direct observation and intervention within the body (in vivo), not for testing samples taken from the body (in vitro).
- Device Description: The description reinforces this by calling it a "digital flexible ureteroscope system," which is a type of endoscope used for internal examination.
- 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 system's function is visualization and facilitating surgical procedures.
Therefore, the URUS System falls under the category of a surgical endoscope or similar device used for direct visualization and intervention, not an IVD.
N/A
Intended Use / Indications for Use
URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FGB
Device Description
The URUS System is a software-controlled single-use digital flexible ureteroscope system. That consist of the single-use digital flexible ureteroscope (DMG-SU100R) and a video processing unit (VP-100). The URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract and the kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / healthcare facility/hospital
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)
- EMC, Wireless, and Electrical, Mechanical and Thermal Safety: The test results demonstrated that the proposed device complies with IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014+A1:2020, IEC TS 60601-4-2:2024, IEC 60601-1- 6:2010/AMD2:2020, and IEC 60601-2-18: 2009.
- Reprocessing, Sterility and Shelf-Life: Sterilization method validated to ISO 11135:2014. EO/ECH residual test performed according to ISO 10993-7:2008. Shelf life (3 years) determined based on stability study including ageing test according to ASTM F1980-16. Package validation conducted according to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886, F88/F88M-21, ASTM F1929-15, and ASTM D4169-22.
- Software, Cybersecurity and Interoperability: Software designed according to IEC 62304. Software information provided in accordance with FDA guidance "Content of Premarket Submissions for - Device Software Functions: Guidance for Industry and Food and Drug Administration Staff', issued on JUNE 2023." and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission".
- Mechanical and acoustic testing:
Optical performance Bench Testing: The URUS System was designed to comply with applicable parts of ISO 8600-1 standard. Tested performance items: Field of View, Depth of Field, Resolution, Distortion, IIU (Image Intensity Uniformity), SNR/DR.
Performance Bench Testing: The URUS System was designed to comply with applicable parts of ISO 8600-1 standard. Tested performance items: Outer Shaft Diameter, Overall length, Working length, Working Channel Diameter, Up/Down Deflection, Direction of View, Depth of Field, Tip Column Strength, Lever Force, Tip to Shaft Tensile Strength, Accessory port, Brightness Control, White balance, Connections tensile strength, Torque and Leakage, Flow rate and pressure, Torque strength, fatigue, Bending path, Leakage. - Biocompatibility: Evaluation performed per ISO 10993-1:2018 and FDA Guidance. Tests conducted based on "externally communicating device contacting tissue/bone/dentin" with contact duration "Limited (
§ 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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September 5, 2024
DYNE Medical Group Inc. % Kim Jong-Hyun Chief Consultant GMS Consulting #B-612, 66 Chengcho-ro Gyeonggi-do. Goyang-si 10543 KOREA, SOUTH
Re: K240203
Trade/Device Name: URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS): URUS System (VP-100/Video Processor) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: January 25, 2024 Received: January 25, 2024
Dear Kim Jong-Hyun:
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/cdrb/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.
1
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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
URUS System (DMG-SU100/URUS);
URUS System (DMG-SU100R/URUS);
URUS System (VP-100/Video Processor)
Indications for Use (Describe)
URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
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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510(K) Summary
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510(k) Summary
K240203
Page 2 of 9
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
JAN 25, 2024
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Manufacturer: DYNE Medical Group Inc.
- Address: #1001-1011, 10F, 165, Gimpohangang 10-ro 133beon-gil, Gimpo-● si, Gyeonggi-do, Republic of Korea 10071
- Contact Name: Young-Hoon Moon / Quality Manager
- -Telephone No .: +82-31-8049-9013 -
- Email Address: yhmoon@dynemedical.com -
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name: URUS System
- Common Name: ureteroscope and accessories, flexible/rigid ●
- Classification: ●
| Classification Name | ureteroscope and accessories, flexible/rigid |
|---|---|
| Classification Number | 21 CFR 876.1500 |
| Product Code | FGB |
| Device Class | II |
| Review Panel | Gastroenterology/Urology |
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Image /page/6/Picture/0 description: The image shows the logo for DYNE MEDICAL GROUP INC. The logo is in black and yellow. Below the logo is the text "K240203 Page 3 of 9".
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follow;
Predicate Device
| ● | 510(k) Number: | K181977 |
|---|---|---|
| ● | Applicant: | OUT Medical Inc. |
| ● | Classification Name: | ureteroscope and accessories, flexible/rigid |
| ● | Trade Name: | WiScope ™ Digital Endoscope System |
5. Description of the Device [21 CFR 807.92(a)(4)]
The URUS System is a software-controlled single-use digital flexible ureteroscope system. That consist of the single-use digital flexible ureteroscope (DMG-SU100R) and a video processing unit (VP-100). The URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.
● URUS System Configurations:
| Model Name | Description |
|---|---|
| DMG-SU100 | URUS Single-Use Digital Flexible Ureteroscope (Standard Deflection) |
| DMG-SU100R | URUS Single-Use Digital Flexible Ureteroscope (Reverse Deflection) |
| VP-100 | URUS System Video Processor |
6. Indications for use [21 CFR 807.92(a)(5)]
URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
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Image /page/7/Picture/0 description: The image shows the logo for DYNE MEDICAL GROUP INC. The logo is in blue and yellow. Below the logo is the text "K240203 Page 4 of 9".
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(4)]
The table below presents comparisons between the subject device (URUS System) and the legally marketed predicate devices (K181977):
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| K Number | K240203 | K181977 | - |
| Manufacturer | DYNE Medical Group Inc. | OUT Medical Inc. | - |
| Trade Name | URUS System | WiScope™ Digital Endoscope | |
| System | - | ||
| Classification | |||
| Name | ureteroscope and accessories, | ||
| flexible/rigid | ureteroscope and accessories, | ||
| flexible/rigid | Same | ||
| Classification | |||
| Regulation | |||
| Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| single-use | Single-Use | Single-Use | Same |
| Image | |||
| System | Not including OS, monitor, and | ||
| battery | Not including OS, monitor, and | ||
| battery | Same | ||
| Environment | |||
| of Use | healthcare facility/hospital | healthcare facility/hospital | Same |
| Intended Use | URUS System is intended to be | ||
| used by physicians to access, | |||
| visualize, and perform | |||
| procedures in the urinary tract | |||
| and the kidney. The instrument | |||
| enables delivery and use of | |||
| accessories such as biopsy | |||
| forceps, laser fibers, graspers | |||
| and retrieval baskets at a | |||
| surgical site. | WiScope™ Digital Endoscope | ||
| System is intended to be used | |||
| by physicians to access, | |||
| visualize, and perform | |||
| procedures in the urinary tract | |||
| and the kidney. The instrument | |||
| enables delivery and use of | |||
| accessories such as biopsy | |||
| forceps, laser fibers, graspers | |||
| and retrieval baskets at a | |||
| surgical site. | Same | ||
| Duration of | |||
| Use | Single-Use, 4h | Single-Use | Same |
| Digital video | |||
| technology | CMOS | CMOS | Same |
| Illumination | Fiber | LED | Different |
| Field of View | |||
| (Diagonal) | 85° | 100° | Different |
| Depth of | |||
| Field (mm) | 3 - 50 mm | 2 - 50 mm | Different |
| Outer Shaft | |||
| Diameter | 9.5F | 8.6Fr | Different |
| [Table 1. Comparison of Proposed Device to Predicate Device] | |||
|---|---|---|---|
| Overall | |||
| length (mm) | 948 mm | 905 mm | Different |
| Working | |||
| Length (mm) | 680 | 670 | Different |
| Up/Down | |||
| Deflection | UP: 270° | ||
| DOWN: 270° | |||
| 0° | UP: 275° | ||
| DOWN: 275° | Different | ||
| Working | |||
| Channel | |||
| Diameter (Fr) | 3.6Fr (1.2mm) | 3.6Fr | Same |
| Direction of | |||
| View | 0° | 0° | Same |
| Brightness | |||
| Control | Yes | Yes | Same |
| White | |||
| Balance | Yes | Yes | Same |
| Output | |||
| Formats | USB/SD CARD/DVI/SDI/VGA | USB/AV/HDMI | Different |
| Image/Video | |||
| Capture | YES | No | Different |
| Sterilization | Ethylene Oxide | ||
| SAL: 10^-6 | Ethylene Oxide | ||
| SAL: 10^-6 | Same | ||
| Packaging | packaged in a tray sealed by | ||
| sterile barrier system | Ureteroscope is packaged in a | ||
| tray which is sealed by sterile | |||
| barrier | Same | ||
| Biologics | · Cytotoxicity | ||
| · Sensitization | |||
| · irritation : | |||
| · Acute systemic toxicity | |||
| · Pyrogenicity | · Cytotoxicity | ||
| · Sensitization | |||
| · irritation : | |||
| · Acute systemic toxicity | |||
| · Pyrogenicity | Same | ||
| Duration and | |||
| type of | |||
| contact | Limited ( |