URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)

K240203 · Dyne Medical Group, Inc. · FGB · Sep 5, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K240203
• Device Name: URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)
• Applicant: Dyne Medical Group, Inc.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Sep 5, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

URUS System is a software-controlled, single-use digital flexible ureteroscope system consisting of a ureteroscope (DMG-SU100/DMG-SU100R) and a video processor (VP-100). Device captures images via CMOS sensor at the distal tip; transmits video to the processor for display. Used by physicians in healthcare facilities/hospitals to access and visualize the urinary tract and kidney; facilitates accessory delivery (biopsy forceps, laser fibers, etc.) for surgical procedures. Output is visualized by the physician on a connected monitor to guide clinical decision-making and intervention. Benefits include single-use design eliminating reprocessing requirements and associated cross-contamination risks.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), endoscopic equipment safety (IEC 60601-2-18), optical performance (ISO 8600-1), biocompatibility (ISO 10993), and sterilization/packaging validation (ISO 11135, ISO 11607).

Technological Characteristics

Single-use digital flexible ureteroscope; CMOS imaging sensor; fiber illumination; 9.5F outer shaft diameter; 3.6Fr working channel; 270° up/down deflection. Sterilized via Ethylene Oxide (SAL 10^-6). Software-controlled video processor (VP-100) with USB/SD/DVI/SDI/VGA outputs. Complies with ISO 8600-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18.

Indications for Use

Indicated for physicians to access, visualize, and perform procedures in the urinary tract and the kidney, including delivery of accessories (biopsy forceps, laser fibers, graspers, retrieval baskets) at a surgical site.

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.

Predicate Devices

• WiScope™ Digital Endoscope System (K181977)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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.

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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 (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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

Submission Number (if known)

K240203

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

Image /page/4/Picture/2 description: The image shows the logo for DYNE MEDICAL GROUP INC. The letters "DYNE" are in a bold, sans-serif font, with the "D" in yellow and the rest of the letters in dark blue. Below the letters, the words "MEDICAL GROUP INC" are in a smaller, sans-serif font, also in dark blue. There is a small yellow circle in the upper right corner of the image.

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Image /page/5/Picture/0 description: The image shows the logo for Dyne Medical Group Inc. The logo is made up of the word "DYNE" in large, bold letters. The "D" and "E" are yellow, while the "Y" and "N" are navy blue. Below the word "DYNE" is the text "MEDICAL GROUP INC" in smaller, black letters.

# 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 .: [phone] -
- Email Address: [e-mail] -

# 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<br>System | - |
| Classification<br>Name | ureteroscope and accessories,<br>flexible/rigid | ureteroscope and accessories,<br>flexible/rigid | Same |
| Classification<br>Regulation<br>Number | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| single-use | Single-Use | Single-Use | Same |
| Image<br>System | Not including OS, monitor, and<br>battery | Not including OS, monitor, and<br>battery | Same |
| Environment<br>of Use | healthcare facility/hospital | healthcare facility/hospital | Same |
| Intended Use | URUS System is intended to be<br>used by physicians to access,<br>visualize, and perform<br>procedures in the urinary tract<br>and the kidney. The instrument<br>enables delivery and use of<br>accessories such as biopsy<br>forceps, laser fibers, graspers<br>and retrieval baskets at a<br>surgical site. | WiScope™ Digital Endoscope<br>System is intended to be used<br>by physicians to access,<br>visualize, and perform<br>procedures in the urinary tract<br>and the kidney. The instrument<br>enables delivery and use of<br>accessories such as biopsy<br>forceps, laser fibers, graspers<br>and retrieval baskets at a<br>surgical site. | Same |
| Duration of<br>Use | Single-Use, 4h | Single-Use | Same |
| Digital video<br>technology | CMOS | CMOS | Same |
| Illumination | Fiber | LED | Different |
| Field of View<br>(Diagonal) | 85° | 100° | Different |
| Depth of<br>Field (mm) | 3 - 50 mm | 2 - 50 mm | Different |
| Outer Shaft<br>Diameter | 9.5F | 8.6Fr | Different |

| | | [Table 1. Comparison of Proposed Device to Predicate Device] | |
|-------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------|
| | | | |
| Overall<br>length (mm) | 948 mm | 905 mm | Different |
| Working<br>Length (mm) | 680 | 670 | Different |
| Up/Down<br>Deflection | UP: 270°<br>DOWN: 270°<br>0° | UP: 275°<br>DOWN: 275° | Different |
| Working<br>Channel<br>Diameter (Fr) | 3.6Fr (1.2mm) | 3.6Fr | Same |
| Direction of<br>View | 0° | 0° | Same |
| Brightness<br>Control | Yes | Yes | Same |
| White<br>Balance | Yes | Yes | Same |
| Output<br>Formats | USB/SD CARD/DVI/SDI/VGA | USB/AV/HDMI | Different |
| Image/Video<br>Capture | YES | No | Different |
| Sterilization | Ethylene Oxide<br>SAL: 10^-6 | Ethylene Oxide<br>SAL: 10^-6 | Same |
| Packaging | packaged in a tray sealed by<br>sterile barrier system | Ureteroscope is packaged in a<br>tray which is sealed by sterile<br>barrier | Same |
| Biologics | · Cytotoxicity<br>· Sensitization<br>· irritation :<br>· Acute systemic toxicity<br>· Pyrogenicity | · Cytotoxicity<br>· Sensitization<br>· irritation :<br>· Acute systemic toxicity<br>· Pyrogenicity | Same |
| Duration and<br>type of<br>contact | Limited (< 24 hours) | Limited (< 24 hours) | Same |
| Label and<br>Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Same |

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Image /page/8/Picture/0 description: The image shows the logo for DYNE Medical Group Inc. The logo features the word "DYNE" in bold, with the "D" in yellow and the rest of the letters in dark blue. Below the logo, the text "MEDICAL GROUP INC" is written in a smaller font. The text "K240203 Page 5 of 9" is at the bottom of the image.

The comparison table shows that the subject device (URUS System) has the similar indications for use the predicate device. (i.e., for collection of physicians to access, visualize, and perform procedures in the urinary tract and the kidney.)

The subject and predicate devices have similar technological features, including Duration of Use, Digital video technology, Working Channel Diameter (Fr), Brightness Control, and White Balance.

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Image /page/9/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 6 of 9" in black.

However, as shown in the table above, there are different technological characteristics (Illumination, Field of View (Diagonal), Depth of Field, Outer Shaft Diameter, Overall length, Working Length (mm), Up/Down Deflection, Output Formats, Image/Video Capture) these differences do not make the subject device less safe and reliable, so the subject device fits for diagnostic use as the predicate device does. There are no significant differences in the technological characteristics of the subject device. All the differences between the subject and predicate device do not raise different questions of safety and effectiveness. Therefore, the test results confirmed that the no significant differences in the technological characteristics of the subject device.

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Image /page/10/Picture/0 description: The image shows the logo for DYNE MEDICAL GROUP INC. The logo features the word "DYNE" in large, bold letters, with the "D" and the top right portion of the "E" in yellow, and the rest of the letters in black. Below the word "DYNE" are the words "MEDICAL GROUP INC" in smaller, black letters. The image also contains the text "K240203 Page 7 of 9".

# 8. PERFORMANCE DATA [21 CFR 807.92(b)(1)]

# 1) EMC, Wireless, and Electrical, Mechanical and Thermal Safety

The test results demonstrated that the proposed device complies with the following standards:

- -Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AMD2:2020
- -Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014+A1:2020
- Medical electrical equipment Part 4-2: Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems With IEC TS 60601-4-2:2024
- -Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Usability in accordance with IEC 60601-1- 6:2010/AMD2:2020
- -Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment with IEC 60601-2-18: 2009

# 2) Reprocessing, Sterility and Shelf-Life

# · Sterilization and shelf life testing

The sterilization method has been validated to ISO 11135:2014, which has thereby determined the routine control and monitoring parameters.

EO/ECH residual test was performed according to ISO 10993-7:2008.

The shelf life (3 years) of the Single-Use Digital Flexible Ureteroscope is determined based on stability study which includes ageing test according to ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier.

# • Package Validation

Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and visual inspection (ASTM F1886), seal strength (F88/F88M-21), dye penetration (ASTM F1929-15), Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM D4169-22).

# 3) Software, Cybersecurity and Interoperability

The software was designed according to IEC 62304 software development process and was verified and validated. According to the guidance, we evaluated the level of Basic level documentation by identifying safety-related characteristics for device documentation level.

- The software information is 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.
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission י

# 4) Mechanical and acoustic testing

All necessary performance testing has been conducted on the URUS System to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test unit representative of finished devices.

The device passed the following tests:

#### 510(k) Summary

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Image /page/11/Picture/0 description: The image shows a logo for DYNE MEDICAL GROUP INC. The logo has the word "DYNE" in large, bold letters, with the "D" and "E" in yellow and the "Y" and "N" in black. Below the word "DYNE" is the text "MEDICAL GROUP INC" in smaller, black letters. Below the logo is the text "K240203" and "Page 8 of 9" in black letters.

### · Optical performance Bench Testing

The URUS System was designed to comply with applicable parts of ISO 8600-1 standard. According to the ISO 8600 standard, we test following 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. According to the ISO 8600 standard, we test following 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 |

# 5) Biocompatibility

The biocompatibility evaluation for the patient contacting components of the Single-Use Digital Flexible Ureteroscope performed according to ISO 10993-1:2018 and FDA Guidance. The following tests were conducted based contact category of "externally communicating device contacting tissue/bone/dentin" with a contact duration of "Limited (< 24 hours):

| - Cytotoxicity | ISO 10993-5:2009 |
|---------------------------|-------------------|
| - Sensitization | ISO 10993-10:2021 |
| - irritation: | ISO 10993-23:2021 |
| - Acute systemic toxicity | ISO 10993-11:2017 |
| - Pyrogenicity | ISO 10993-11:2017 |

# 6) Clinical Test Summary:

The subject of this premarket submission did not require clinical studies were considered necessary and performed.

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Image /page/12/Picture/0 description: The image shows the logo for DYNE MEDICAL GROUP INC. The logo has the word "DYNE" in bold, dark blue letters, with the "D" and "E" highlighted in yellow. Below the logo, the text "MEDICAL GROUP INC" is written in smaller, dark blue letters. Below the logo is the text "K240203 Page 9 9 8".

# 9. Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification DTNE Medical Group Inc., concludes that the URUS System is substantially equivalent in safety and effectiveness to the predicate devices as described herein.