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.

Device Description

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.

AI/ML Overview

This document pertains to the FDA 510(k) premarket notification for the Medical Thulium Fiber Laser System (UroFiber 60Q) manufactured by Rhein Laser Technologies Co., Ltd. The information provided outlines the device's characteristics and its comparison to predicate and reference devices to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria for an AI/software-as-a-medical-device (SaMD) product.

Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, and how ground truth was established for the training set is not applicable and not present in the provided document.

This document describes a traditional medical device (a laser surgical instrument), and the testing described is primarily for electrical safety, electromagnetic compatibility, and biocompatibility, as well as a comparison of its technical specifications and intended use against legally marketed predicate devices.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/SaMD criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (as implied by FDA 510(k) for a device like this): Substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This is demonstrated through non-clinical performance data (compliance with general and particular medical device standards) rather than clinical performance metrics or AI algorithm performance metrics.

Reported Device Performance: The document states that "Performance data supports that the device is as safe and effective as the predicate/reference devices for its intended use." Specific performance aspects tested include:

Safety of Laser Products (IEC 60825-1:2014)
Medical Electrical Equipment (IEC 60601-1:2005+AMD1:2012+AMD2:2020)
Electromagnetic Disturbances (IEC 60601-1-2:2014+AMD1:2020)
Particular Requirements for Surgical Laser Equipment (IEC 60601-2-22:2019)
Biocompatibility (ISO 10993 series: Parts 10, 23, 5, 11, 4)

Acceptance Criteria (Implied by Standards & Substantial Equivalence)	Reported Device Performance (Compliance)
Laser Safety Compliance	Complies with IEC 60825-1:2014
Electrical Safety & Essential Performance	Complies with IEC 60601-1:2005+AMD1:2012+AMD2:2020
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014+AMD1:2020
Specific Surgical Laser Equipment Safety	Complies with IEC 60601-2-22:2019
Biocompatibility (Skin Sensitization, Irritation, Cytotoxicity, Systemic Toxicity, Blood Interaction)	Complies with ISO 10993-10, -23, -5, -11, -4; found to be biocompatible

2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable. This isn't an AI/SaMD. The "test set" in this context refers to the physical device being tested against recognized consensus standards for electrical, laser, and biological safety. The "data provenance" specifically for patient data or images (as would be relevant for AI) is not relevant for this type of device submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
* Not applicable. This is not an AI/SaMD. Ground truth, in the AI context, refers to a definitive correct answer for patient data, often established by experts. For this laser device, "ground truth" is adherence to engineering and safety standards, not a clinical assessment of data by experts in the same way.

4. Adjudication Method:
* Not applicable. No clinical data interpretation by multiple readers is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No. This type of study is specifically relevant for assessing the impact of AI on human reader performance, which is not the subject of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. No algorithm performance is being evaluated.

7. The Type of Ground Truth Used:
* Not applicable. For this laser device, the "ground truth" of its safety and effectiveness is demonstrated by its adherence to established national and international engineering, electrical, laser, and biocompatibility standards, and its substantial equivalence to legally marketed predicate devices with a history of safe use. There is no "pathology," "outcomes data," or "expert consensus" in the sense of clinical interpretations for an algorithm.

8. The Sample Size for the Training Set:
* Not applicable. This device does not involve a training set as it is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established:
* Not applicable. No training set exists for this device.

In summary, the provided document is a standard FDA 510(k) clearance letter and summary for a physical medical device (a laser system), not an AI/SaMD. Therefore, it does not contain the specific information requested regarding acceptance criteria and performance studies for an AI device.

Summary

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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 (1-800-638-2041 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)

	Prescription Use (Part 21 CFR 801 Subpart D)
	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: +86-027-65279157 Email: na.wu@rheinlaser.com

Proposed Device 2.

Trade Name:	Medical Thulium Fiber Laser System (UroFiber 60Q)
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
Model(s):	UroFiber 60Q
Classification RegulationNumber:	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 andplastic 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 andplastic surgery and in dermatology
Trade Name:	SOLTIVE™ Laser System (SOLTIVE™ ProSuperPulsed Laser, SOLTIVE™ PremiumSuperPulsed Laser, SOLTIVE™Laser Fibers, andAccessories)

Device Description 5.

6. Indications for Use

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(K210142)	Reference Device(K183647)	Remarks
Manufacturer	Rhein LaserTechnologies Co.,Ltd.	Quanta System Spa	Olympus SurgicalTechnologiesAmerica
Device Name	Medical ThuliumFiber LaserSystems	Fiber Dust	SOLTIVE™ LaserSystem
Model(s)	UroFiber 60Q	Not Specified	Not Specified
Intended Use	Medical Thulium FiberLaser System(UroFiber 60Q) isintended for incision,excision, resection,ablation, coagulation,hemostasis, andvaporization of softtissuewith or withoutan endoscope, in thefollowing indications:urology, lithotripsy,gastroenterologicalsurgery andgynecological surgery.	The predicate device(K210142) Fiber Dust isintended for incision,excision, resection,ablation, coagulation,hemostasis, andvaporization of softtissue, with or without anendoscope, in thefollowing indications:urology, lithotripsy,gastroenterologicalsurgery andgynecological surgery.	The reference device(K183647) SOLTIVETMLaser System is intendedfor incision, excision,resection, ablation,coagulation, hemostasis,and vaporization of softtissue, with or without anendoscope, in thefollowing indications:urology, lithotripsy,gastroenterologicalsurgery andgynecological 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 AveragePower	60 W	60 W	60 W	Same
CoolingSystem	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.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.