Single-use Sterile medical laser fiber

K202601 · Realton (Suzhou) Medical Technology Co., Ltd. · GEX · Dec 15, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K202601
• Device Name: Single-use Sterile medical laser fiber
• Applicant: Realton (Suzhou) Medical Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostate for benign prostatic hyperplasia (BPH).

Device Story

Single-use sterile fiber optic delivery device; transmits 532 nm laser energy from compatible Surgical Green Laser System to target tissue. Available in side-firing and front-firing configurations; utilizes fused quartz fiber with 760 µm core diameter. Used in surgical settings by physicians for soft tissue procedures, including BPH treatment. Device connects to laser console via SMA-905 connector. Delivers laser energy to achieve incision, excision, vaporization, ablation, hemostasis, or coagulation. Benefits include precise tissue interaction during minimally invasive procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation, systemic toxicity). Performance testing evaluated dimensions, optical performance (transmission efficiency), mechanical strength (tensile, bending), and shelf life. All parameters met predefined acceptance criteria.

Technological Characteristics

Fused quartz optical fiber; 760 µm core diameter; 300 cm length; SMA-905 connector. Side-firing and front-firing configurations. Sterilized via ethylene oxide (EO). Compatible with 532 nm laser systems. Max power 180 W. Minimum transmission efficiency 80%.

Indications for Use

Indicated for surgical incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue (skin, muscle, cartilage, organs, glands, etc.) and photo-selective vaporization of the prostate for BPH. Contraindicated in severe urethral strictures.

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

• GreenLight MoXyTM Fiber Optic (K120870)

Submission Summary (Full Text)

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December 15, 2020

Realton (Suzhou) Medical Technology Co., Ltd % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd 8-9th Floor, R&D Building, No. 26 Oinglan Street, Panvu District Guangzhou, Guangdong 510006, China

Re: K202601

Trade/Device Name: Single-use sterile medical laser fiber 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: November 26, 2020 Received: November 30, 2020

Dear Olivia Meng:

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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/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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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K202601

Device Name Single-use sterile medical laser fiber

### Indications for Use (Describe)

The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use. The product can be used for the surgical incision/excision, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostatic hyperplasia (BPH).

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

- 1. SUBMITTER
Realton (Suzhou) Medical Technology Co., Ltd.

601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park, Suzhou, P.R.China Phone: [phone]

| Primary Contact | Olivia Meng |
|--------------------|----------------------------------------------------------------------------------------------|
| Person: | Regulatory Affairs Manager |
| | Guangzhou Osmunda Medical Device Technical Service |
| | Co., Ltd. |
| | 8-9th Floor, R&D Building, No. 26 Qinglan Street, Panyu |
| | District, Guangzhou, CHN 510006 Guangdong |
| | Tel: [phone] |
| | Fax: (+86) -20-8633 0253 |
| Secondary Contact | Mingzhu Liu |
| Person: | Quality Manager |
| | Realton (Suzhou) Medical Technology Co., Ltd. |
| | Tel: [phone] |
| Date prepared | December 11, 2020 |
| 2. DEVICE | |
| Device Name: | Single-use sterile medical laser fiber |
| Common/Usual Name: | Single-use sterile medical laser fiber |
| Model: | W760SF-30, B760SF-30, G760SF-30, P760SF-30, W760F-<br>30, B760FF-30, G760FF-30 and P760FF-30 |
| Regulation number | 21 CFR 878.4810 |
| Regulation Class: | II |
| Product Code: | GEX (Powered Laser Surgical Instrument) |
| Regulation Name: | Laser Surgical Instrument for Use in General and Plastic Surgery and In<br>Dermatology |

#### PREDICATE DEVICE 3.

K120870 GreenLight MoXyTM Fiber Optic

- 4. DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image shows the logo for Realton Realtime Corporation. The logo is white text on a green background. The logo consists of a stylized "R" symbol to the left of the word "REALTON" in all caps. Below the word "REALTON" is the text "Realtime Corporation" in a smaller font.

The single-use sterile medical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. The optical fiber material is fused quartz, and its core diameter is 760 µm. One end of the optical fiber is a special connector, which can be connected to the medical laser surgery system. The output structure of the other end of the optical fiber can be divided into side-firing type and front-firing type: W760SF-30, B760SF-30, G760SF-30 and P760SF-30 are side-firing types, W760F-30, B760FF-30, G760FF-30 and P760FF-30 are front-firing types.

The product is sterilized by EO. It is a disposable medical device.

| Item | Specification |
|----------------------------------------|---------------|
| Overall Length | 300 cm |
| Core Diameter | 0.76 mm |
| Applicable wave lengths | 532 nm |
| Minimum transmission efficiency | 80 % |
| Maximum transmission power | 180 W |
| Tensile strength | 10 N |
| Minimum bending working radius | 500 mm |
| Light output angle (side-firing types) | 70°± 20° |
| Connector | SMA-905 |

The specification of the single- use sterile medical laser fiber is as followed:

#### 5. INDICATIONS FOR USE

The device is a fiber optic delivery device intended for use with the laser system for its FDA cleared indications for use.

The product can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

The product will deliver 532 nm laser energy from a compatible laser console (Surgical Green Laser System) to tissue during surgical procedures, including photo-selective vaporization of the prostate for benign prostatic hyperplasia (BPH).

The indications for use statement for the subject device is same as the predicate device.

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| Specification | Subject device | Predicate device | Discussion<br>of<br>difference |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Device name | Single-use Sterile Medical Laser Fiber | GreenLight MoXy™ Fiber Optic | NA |
| Manufacturer | Realton (Suzhou) Medical Technology<br>Co., Ltd. | American Medical Systems | NA |
| 510<br>(k)<br>number | NA | K120870 | NA |
| Product code | GEX | GEX | Same |
| Intended use | The device is a fiber optic delivery device<br>intended for use with the laser system<br>for its FDA cleared indications for use.<br>The product can be used for the surgical<br>incision/excision, vaporization, ablation,<br>hemostasis and coagulation of soft<br>tissue. All soft tissue is included, such as<br>skin, cutaneous tissue, subcutaneous<br>tissue, striated and smooth tissue,<br>muscle, cartilage meniscus, mucous<br>membrane, lymph vessels and nodes,<br>organs and glands.<br>The product will deliver 532 nm laser<br>energy from a compatible laser console<br>(Surgical Green Laser System) to tissue<br>during surgical procedures, including<br>photo-selective vaporization of the<br>prostate for benign prostatic hyperplasia<br>(BPH). | Model Number 0010-2400 is a fiber<br>optic delivery device intended for use<br>with the GreenLight™ XPS Laser<br>System for its FDA cleared indications<br>for use.<br>The Model Number 0010-2400<br>features a side firing mechanism<br>delivering up to 180W of 532nm light<br>to tissue. Model Number 0010-2400<br>can be used for the surgical<br>incision/excision, vaporization,<br>ablation, hemostasis and coagulation<br>of soft tissue. All soft tissue is included,<br>such as skin, cutaneous tissue,<br>subcutaneous tissue, striated and<br>smooth tissue, muscle, cartilage<br>meniscus, mucous membrane, lymph<br>vessels and nodes, organs and glands.<br>Model Number 0010-2400 will deliver<br>532 nm laser energy from a compatible<br>laser console (GreenLight™ XPS Laser<br>System) to tissue during surgical<br>procedures, including photoselective<br>vaporization of the prostate for benign<br>prostatic hyperplasia (BPH). | Same |
| Contraindica-<br>tions | The fiber is contraindicated in the<br>presence of severe urethral strictures;<br>however, the system can be used in the<br>treatment of urethral strictures with<br>proper cautions. A severe stricture is any<br>stricture with visible narrowing via<br>urethrography or ultrasonography, with<br>near total obstruction that make passage<br>of instruments difficult or dangerous. | The fiber is contraindicated in the<br>presence of severe urethral strictures;<br>however, the system can be used in<br>the treatment of urethral strictures<br>with proper cautions. A severe<br>stricture is any stricture with visible<br>narrowing via urethrography or<br>ultrasonography, with near total<br>obstruction that make passage of<br>instruments difficult or dangerous. | Same |
| Prescription or<br>OTC | Prescription | Prescription | Same |
| Components | The device is mainly composed of four<br>parts: fiber connect part (cap for<br>connector, connector), fiber<br>transmission part, fiber handle and<br>treatment part (Side-firing type: bare | The device is mainly composed of<br>metal cap, laser firing point, outer<br>flow tubing, control knob, fiber<br>handle, inlet flow tubing and<br>connector, etc. | Similar |
| | indicator and fiber cap; front-firing type:<br>bare fiber and laser firing point). | | |
| Type | Front-firing and side-firing | Side-firing | Similar |
| Material<br>of<br>fiber | Fused quartz | Fused quartz | Same |
| Fiber core size | 0.76 mm | 0.75 mm | Similar |
| Catheter<br>length | 300 cm | 305 cm | Similar |
| Operation<br>length | 34.5 cm | 36 cm | Similar |
| Power density<br>at 2 mm | @180W=326 W/mm2<br>@120W=218 W/mm2 | @180W=326 W/mm2<br>@120W=218 W/mm2 | Same |
| Applicable<br>wave lengths | 532 nm | 532nm | Same |
| Maximum<br>transmission<br>power | 180 W | 180 W | Same |
| Total amount<br>of energy<br>transferred | 643 KJ | 643 KJ | Same |
| Connector | SMA-905 standard optical connector | Optical Connector | Different |
| Laser systems<br>compatibility | Surgical Green Laser System | GreenLight™ XPS Laser System | Different |
| Endoscope/Cy<br>stoscope<br>compatibility | 24 Fr continuous flow | 22 to 24 Fr continuous flow | Similar |
| Sterilization | Ethylene oxide | Ethylene oxide | Same |

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The indications for use and technological characteristics of the subject and predicate devices are comparable. The subject device and the predicate device differ in some technical specifications such as components, connector and compatible laser systems. However, these differences do not raise different questions of safety and effectiveness.

## 7. SUMMARY OF NON-CLINICAL TESTING

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

The biocompatibility evaluation for single-use sterile medical laser fiber was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation

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of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

- Cytotoxicity
- Sensitization ●
- Irritation
- Systemic toxicity

## Performance testing

Performance testing was conducted on single-use sterile medical laser fiber. Technical parameters about dimension, optical performance and mechanical strength were evaluated in the performance testing. In addition, the shelf life was evaluated. All of the tested parameters met the predefined acceptance criteria.

## 8. CONCLUSION

The indications for use statement for the subject device is the same as that of the predicate. The differences between the subject device and its predicate device do not raise different questions of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that single-use sterile medical laser fiber should perform as intended in the specified application conditions.

From the results of non-clinical data including the performance testing described, Realton (Suzhou) concludes that the subject device single-use sterile medical laser fiber is substantially equivalent to the predicate device.