(109 days)
No
The summary describes a laser system for soft tissue procedures and does not mention any AI or ML components or functionalities.
Yes
The device is intended for various medical procedures such as incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue for therapeutic purposes.
No
The "Intended Use / Indications for Use" section specifies that the device is intended for "incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue," which are all therapeutic or surgical procedures, not diagnostic ones.
No
The device description explicitly lists hardware components such as a host (including power supply, laser, safety control module, cooling module), foot switch, and optical fiber. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue" in various surgical procedures. This describes a therapeutic or surgical device that acts directly on the patient's body.
- Device Description: The description details a laser system with components like a power supply, laser source, and optical fiber. These are typical components of a surgical laser, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are designed to diagnose diseases or conditions by examining these types of samples.
Therefore, the Medical Thulium Fiber Laser System (UroFiber 60Q) is a surgical laser system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
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
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "Administration".
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.
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 820.70) 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).
2
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
3
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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4
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 plastic |
| surgery and in dermatology | |
| Model(s): | UroFiber 60Q |
| Classification Regulation | |
| 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 |
| 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 |
|---|---|
| ---------------- | --------- |
5
| Applicant: | Olympus Surgical Technologies America |
|---|---|
| Classification Name: | Laser surgical instrument for use in general and |
| plastic surgery and in dermatology | |
| Trade Name: | SOLTIVE™ Laser System (SOLTIVE™ Pro |
| SuperPulsed Laser, SOLTIVE™ Premium | |
| SuperPulsed Laser, SOLTIVE™Laser Fibers, and | |
| 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
6
| Feature | Proposed Device | Predicate Device
(K210142) | Reference Device
(K183647) | Remarks |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Manufacturer | Rhein Laser
Technologies Co.,
Ltd. | Quanta System Spa | Olympus Surgical
Technologies
America | |
| Device Name | Medical Thulium
Fiber Laser
Systems | Fiber Dust | SOLTIVE™ Laser
System | |
| Model(s) | UroFiber 60Q | Not Specified | Not Specified | |
| Intended 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. | The predicate device
(K210142) Fiber Dust 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. | The reference device
(K183647) SOLTIVETM
Laser System 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. | 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 | 500550 nm | Same |6 J | 0.02
| Pulse Width | 0.1 to 15 ms | 0.1 to 15 ms | 0.2 to 50 ms | Same |
| Pulse Energy | 0.026 J | 0.0256 J | Same |
| Frequency | 12500 Hz | 12500 Hz | 1~2400 Hz | Same |
| Max Average
Power | 60 W | 60 W | 60 W | Same |
| Cooling
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
7
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
8
Thulium Fiber Laser System (UroFiber 60Q) is found to have a safety and effectiveness profile that is similar to the predicate/reference devices.