Medical Thulium Fiber Laser Systems (UroFiber 60Q)

K242293 · Rhein Laser Technologies Co., Ltd. · GEX · Nov 19, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K242293
• Device Name: Medical Thulium Fiber Laser Systems (UroFiber 60Q)
• Applicant: Rhein Laser Technologies Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Medical Thulium Fiber Laser System (UroFiber 60Q) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Device Story

System uses 1940 nm thulium fiber laser to perform soft tissue surgery; includes host unit with power supply, cooling module, safety control module, foot switch, and disposable optical fibers. Operated by clinicians in surgical settings; laser energy delivered via fiber to target tissue for incision, ablation, or hemostasis. System provides CW/pulsed emission modes; aiming beam (532 nm) assists targeting. Output parameters (energy, frequency, pulse width) controlled by user to achieve desired surgical effect. Benefits include precise tissue interaction for urological and surgical procedures.

Clinical Evidence

Bench testing only. Compliance with IEC 60825-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and ISO 10993 series (biocompatibility: sensitization, irritation, cytotoxicity, systemic toxicity, blood interaction) demonstrated.

Technological Characteristics

Thulium fiber laser; 1940 nm wavelength; 532 nm aiming beam; CW/pulsed emission; 0.02-6 J pulse energy; 1-2500 Hz frequency; 60 W max average power; air cooling. Disposable optical fibers (models RL-150 to RL-1000). Standards: IEC 60825-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, ISO 10993.

Indications for Use

Indicated for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue in urology, lithotripsy, gastroenterological surgery, and gynecological surgery, with or without an endoscope.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Fiber Dust (K210142)

Reference Devices

• SOLTIVE™ Laser System (K183647)

Submission Summary (Full Text)

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Novembeer 19, 2024

Rhein Laser Technologies Co., Ltd. Na Wu Quality Manager 801.8F, E2 Building, Future City, No.999 High-Tech Avenue, East Lake High-Tech Development Zone Wuhan, 430206 China

Re: K242293

Trade/Device Name: Medical Thulium Fiber Laser System (UroFiber 600) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: August 2, 2024 Received: August 2, 2024

Dear Na Wu:

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/ofdocs/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 820.70) 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 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 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).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@;tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -S Date: 2024.11.19
21:33:57 -05'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K242293

Device Name

Medical Thulium Fiber Laser System (UroFiber 600)

Indications for Use (Describe)

Medical Thulium Fiber Laser System (UroFiber 600) is intended for incision, resection, ablation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Type of Use (Select one or both, as applicable)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

Medical Thulium Fiber Laser System (UroFiber 60Q)

Date of Summary Preparation: August 01, 2024 Date of Summary Modification: November 15, 2024

#### Applicant Information 1.

Rhein Laser Technologies Co., Ltd. 801,8F, E2 Building, Future City, No.999 High-Tech Avenue, East Lake High-Tech Development Zone, Wuhan 430206, China ( Free Trade Zone Wuhan Area) Contact Person: Na Wu Quality Manager Title: Telephone Number: [phone] Email: [e-mail]

#### Proposed Device 2.

| Trade Name: | Medical Thulium Fiber Laser System (UroFiber 60Q) |
|--------------------------------------|----------------------------------------------------------------------------------------|
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology |
| Model(s): | UroFiber 60Q |
| Classification Regulation<br>Number: | 21 CFR 878.4810 |
| Product Code: | GEX (Powered Laser Surgical Instrument) |
| Device Class: | II |
| FDA CDRH Review Panel: | General & Plastic Surgery |

#### Predicate Device(s) 3.

| 510(k) Number: | K210142 |
|----------------------|----------------------------------------------------------------------------------------|
| Applicant: | Quanta System Spa |
| Classification Name: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology |
| Trade Name: | Fiber Dust |

This predicate has not been subject to a design-related recall.

#### Reference Device(s) 4.

| 510(k) Number: | K183647 |
|----------------|---------|
|----------------|---------|

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| Applicant: | Olympus Surgical Technologies America |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Laser surgical instrument for use in general and<br>plastic surgery and in dermatology |
| Trade Name: | SOLTIVE™ Laser System (SOLTIVE™ Pro<br>SuperPulsed Laser, SOLTIVE™ Premium<br>SuperPulsed Laser, SOLTIVE™Laser Fibers, and<br>Accessories) |

#### Device Description 5.

Medical Thulium Fiber Laser System (UroFiber 60Q) consists of a host (including a power supply, thulium fiber laser, safety conrol module, cooling module), foot switch and optical fiber (disposable use, sterilized by the user before use. Model: RL-150, RL-200, RL-272, RL-365, RL-550, RL-800, RL-1000, specification: 300) composition. Protective glasses not included.

#### 6. Indications for Use

Medical Thulium Fiber Laser System (UroFiber 60Q) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissuewith or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

### 7. Comparison to the Predicate Device(s) Indications for Use/Intended Use:

The subject Medical Thulium Fiber Laser System (UroFiber 60Q) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissuewith or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery, while the predicate device (K210142, Fiber Dust) intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. All devices share the same application and the same 1940 nm laser wavelengath for treatment.

Technological Characteristics: The subject Medical Thulium Fiber Laser System 8. (UroFiber 600) has the same intended use, principle of operation and technical characteristics as the predicate/reference devices. Performance data supports that the device is as safe and effective as the predicate/reference devices for its intended use.

#### Comparison between UroFiber 60Q and the Predicate/Reference Devices Table 1

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| Feature | Proposed Device | Predicate Device<br>(K210142) | Reference Device<br>(K183647) | Remarks |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Manufacturer | Rhein Laser<br>Technologies Co.,<br>Ltd. | Quanta System Spa | Olympus Surgical<br>Technologies<br>America | |
| Device Name | Medical Thulium<br>Fiber Laser<br>Systems | Fiber Dust | SOLTIVE™ Laser<br>System | |
| Model(s) | UroFiber 60Q | Not Specified | Not Specified | |
| Intended Use | Medical Thulium Fiber<br>Laser System<br>(UroFiber 60Q) is<br>intended for incision,<br>excision, resection,<br>ablation, coagulation,<br>hemostasis, and<br>vaporization of soft<br>tissuewith or without<br>an endoscope, in the<br>following indications:<br>urology, lithotripsy,<br>gastroenterological<br>surgery and<br>gynecological surgery. | The predicate device<br>(K210142) Fiber Dust is<br>intended for incision,<br>excision, resection,<br>ablation, coagulation,<br>hemostasis, and<br>vaporization of soft<br>tissue, with or without an<br>endoscope, in the<br>following indications:<br>urology, lithotripsy,<br>gastroenterological<br>surgery and<br>gynecological surgery. | The reference device<br>(K183647) SOLTIVETM<br>Laser System is intended<br>for incision, excision,<br>resection, ablation,<br>coagulation, hemostasis,<br>and vaporization of soft<br>tissue, with or without an<br>endoscope, in the<br>following indications:<br>urology, lithotripsy,<br>gastroenterological<br>surgery and<br>gynecological surgery. | Same |
| Laser Source | Thulium Laser | Thulium Laser | Thulium Laser | Same |
| Wavelength | 1940 nm | 1940 nm | 1940 nm | Same |
| Emission | CW/Pulsed | CW/Pulsed | CW/Pulsed | Same |
| Aiming Beam | 532 nm | 532 nm | 500~550 nm | Same |
| Pulse Width | 0.1 to 15 ms | 0.1 to 15 ms | 0.2 to 50 ms | Same |
| Pulse Energy | 0.02~6 J | 0.02~6 J | 0.025~6 J | Same |
| Frequency | 1~2500 Hz | 1~2500 Hz | 1~2400 Hz | Same |
| Max Average<br>Power | 60 W | 60 W | 60 W | Same |
| Cooling<br>System | Air Cooling | Air Cooling | Air Cooling | Same |

#### 8. Performance Data

The following performance data are provided in support of the substantial equivalence determination:

The proposed device performs testing in accordance with the following recognized consensus standards:

IEC 60825-1:2014 Safety of Laser Products - Part 1: Equipment Classification and Requirements

IEC 60601-1:2005+AMD1:2012+AMD2:2020 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance

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IEC 60601-1-2:2014+AMD1:2020 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests

IEC 60601-2-22:2019 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

ISO10993-10 Fourth edition 2021-11:Biological evaluation of medical devices -Part 10: Tests for skin sensitization

ISO10993-23 First edition 2021-01 Biological evaluation of medical devices -Part 23: Tests for irritation

ISO10993-5: 2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity and found to be biocompatible

ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

ISO 10993-4: 2017 Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood

#### Clinical/Animal Testing 9.

The information included in this premarket notification included the following: product code, regulation number, device class , controls, indications for use, wavelength, laser source, emission, aiming beam, pulse width, pulse width, pulse energy, frequency, maximum average power, cooling system, delivery system, software, delivery devices and electromagnetic compatibility and electrical safety compliance, and the non-clinical tests complied with the requirements of relevant recognized standards. The proposed Medical Thulium Fiber Laser System (UroFiber 60Q) device is not considered to need new animal or clinical testing.

#### 10. Conclusions

Based on the above performance as documented in this application, the Medical

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Thulium Fiber Laser System (UroFiber 60Q) is found to have a safety and effectiveness profile that is similar to the predicate/reference devices.