FLARE Single-Use Surgical Laser Fiber

K202702 · Realton (Suzhou) Medical Technology Co., Ltd. · GEX · Feb 26, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202702
• Device Name: FLARE Single-Use Surgical Laser Fiber
• Applicant: Realton (Suzhou) Medical Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FLARE™ single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm- 2140 nm and equipped with SMA 905 compatible connector. FLARE™ single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.

Device Story

FLARE single-use surgical laser fiber delivers laser energy from compatible surgical lasers to target tissue. Device consists of fused quartz optical fiber with SMA 905 connector. Used in open, laparoscopic, and endoscopic procedures; operated by physicians. Fiber transmits laser radiation for ablation, vaporization, excision, incision, coagulation, and lithotripsy. Disposable device sterilized by EO. Clinical benefit derived from precise delivery of laser energy to soft tissue or calculi, facilitating surgical intervention.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2018 (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity) and ASTM F756-17 (hemocompatibility). Performance testing evaluated dimensions, optical performance, mechanical strength, and shelf life. All parameters met predefined acceptance criteria.

Technological Characteristics

Material: Fused quartz. Energy: Laser radiation (532-2140 nm). Connector: SMA 905 standard optical connector. Form factor: Single-use fiber with protective sleeve. Sterilization: Ethylene oxide. No software or electronic components.

Indications for Use

Indicated for general surgical applications including open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue, and lithotripsy. Compatible with surgical lasers (532 nm-2140 nm) with SMA 905 connectors.

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

• SlimLine™ Family of Delivery Fibers (K170121)

Submission Summary (Full Text)

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February 26, 2021

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, Panyu District Guangzhou, Guangdong 510006 China

Re: K202702

Trade/Device Name: FLARE Single-Use Surgical 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: January 22, 2021 Received: January 25, 2021

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 (QS) 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202702

#### Device Name

FLARETM single-use surgical laser fiber

Indications for Use (Describe)

FLARETM single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm-2140 mm and equipped with SMA 905 compatible connector.

FLARETM single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|--|
| <span style="font-family: DejaVu Sans, sans-serif">✘</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |

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Image /page/3/Picture/1 description: The image shows the logo for EALTON Realtime Corporation. The logo is white text on a green background. The logo consists of a stylized letter "E" and the word "EALTON" in all caps. Below the word "EALTON" is the phrase "Realtime Corporation" in a smaller font.

# 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<br>Co., Ltd. |
| | Tel: [phone] |
| | Fax: (+86) -20-8633 0253 |
| Secondary Contact | Mingzhu Liu |
| Person: | Quality Manager |
| | Realton (Suzhou) Medical Technology Co., Ltd. |
| | Tel: [phone] |
| Date prepared | February 24, 2021 |
| 2. DEVICE | |
| Device Name: | FLARE™ single-use surgical laser fiber |
| Common/Usual Name: | FLARE™ single-use surgical laser fiber |
| Model: | RLT105L1, RLT200L1, RLT272L1, RLT365-550L1, RLT365-<br>730L1, RLT550L1, RLT600L1, RLT760L1, RLT940L1,<br>RLT105S1, RLT200S1, RLT272S1, RLT365-550S1, RLT365-<br>730S1, RLT550S1, RLT600S1, RLT760S1, RLT940S1 |
| Regulation number | 21 CFR 878.4810 |
| Regulation Class: | II |
| Product Code: | GEX Powered Laser Surgical Instrument |

- 3. PREDICATE DEVICE
SlimLine™ Family of Delivery Fibers, K170121

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#### DEVICE DESCRIPTION 4.

FLARE™ single-use surgical laser fiber is designed, manufactured by Realton (Suzhou) Medical Technology Co., Ltd.. The optical fiber material is fused quartz. One end of the fiber is connected to the medical laser equipment through a connector, and the other end directly outputs laser energy for laser operation. The product is sterilized by EO. It is a disposable medical device.

### 5. Indications for USE

FLARE™ single-use surgical laser fiber is intended to be used to deliver the laser radiation to the target tissue when used with compatible surgical lasers with operational wavelength between 532 nm- 2140 nm and equipped with SMA 905 compatible connector.

FLARE™ single-use surgical laser fiber is indicated for use in general surgical applications for open, laparoscopic, and endoscopic ablation, excision, excision, incision, coagulation of soft tissue and for lithotripsy.

| Specification | Subject device | Predicate device | Discussion of<br>difference | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------|---------|
| Trade name | FLARETM single-use surgical<br>laser fiber | Lumenis Family of Holmium Surgical<br>Lasers and Delivery Devices and<br>Accessories (VersaPulse<br>PowerSuite, Lumenis Pulse 30H,<br>Lumenis Pulse 50H, Lumenis Pulse<br>60H, Lumenis Pulse 100H and<br>Lumenis Pulse 120H) | NA | | |
| Device name | FLARETM single-use surgical<br>laser fiber | SlimLineTM Family of Delivery Fibers | NA | | |
| Manufacturer | Realton (Suzhou) Medical<br>Technology Co., Ltd. | Lumenis Ltd. | NA | | |
| 510 (k)<br>number | K202702 | K170121 | NA | | |
| Product code | GEX | GEX | Same | | |
| Intended use | FLARETM single-use surgical<br>laser fiber is intended to be<br>used to deliver the laser<br>radiation to the target tissue<br>when used with compatible<br>surgical lasers with operational<br>wavelength between 532 nm-<br>2140 nm and equipped with<br>SMA 905 compatible | Lumenis SlimLine fiber are intended<br>for use with compatible lasers in<br>surgical procedures involving open,<br>laparoscopic, and endoscopic<br>ablation, vaporization, excision,<br>incision, coagulation of soft tissue<br>and for lithotripsy. | Similar | | |
| | | | R202702 | | |
| | connector.<br>FLARE™ single-use surgical<br>laser fiber is indicated for use<br>in general surgical applications<br>for open, laparoscopic, and<br>endoscopic ablation,<br>vaporization, excision, incision,<br>coagulation of soft tissue and<br>for lithotripsy. | | | | |
| | Contraindications | Refer to the laser operator's<br>manual for contraindications<br>that may be specific to each<br>specialty. | | Refer to the laser operator's<br>manual for contraindications that<br>may be specific to each specialty. | Same |
| | Prescription or<br>OTC | Prescription | | Prescription | Same |
| | Components | The device is mainly composed<br>of connector and bare fiber.<br>Protective sleeve is around the<br>bare fiber. | | The fiber consists of a laser<br>connector and a glass fiber. | Similar |
| | Material of<br>fiber | Fused quartz | | Fused quartz | Same |
| | Fiber core<br>diameter<br>(μm) | 105, 200, 272, 365, 550, 600,<br>760, 940 | | 272, 365, 550, 940 | Similar |
| | Fiber outer<br>diameter<br>(mm) | 0.25, 0.40, 0.42, 0.55, 0.73,<br>0.75, 1.10, 1.40 | | 0.45, 0.58, 0.78, 1.45 | Similar |
| | Fiber length | 250 cm, 300 cm | | 250 cm, 310 cm, 450 cm | Similar |
| | Applicable<br>wave lengths | 532nm~2140nm | | 532nm~2140nm | Same |
| Maximum<br>transmission<br>power | 20 W, 100W, 120 W | 15W, 45W, 120W | Similar | | |
| Minimum<br>bending<br>working radius<br>(mm) | 12, 20, 24 | 12, 14, 20, 24 | Similar | | |
| Connector | SMA-905 standard optical<br>connector | Secure identification system | Different | | |
| Laser systems<br>compatibility | Applied to lasers with<br>wavelengths from 532 nm to<br>2140 nm. | VersaPulse™ PowerSuite™ Single<br>Wavelength Horimium<br>VersaPulse PowerSuite Dual<br>Wavelength<br>VersaPulse P20<br>Lumenis Pulse™ 120H | Different | | |
| Sterilization | Ethylene oxide | Ethylene oxide | Same | | |

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6.

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Image /page/5/Picture/0 description: The image shows the logo for EALTON Real Estate Corporation. The logo is white text on a green background. The logo includes a stylized letter "R" to the left of the word "EALTON".

The subject device and the predicate device are similar in some technical specification

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Image /page/6/Picture/0 description: The image shows the logo for Realton Corporation. The logo is green and white. The logo has a symbol on the left and the word "REALTON" in large, bold letters on the right. Below the word "REALTON" is the phrase "Realton Corporation" in smaller letters.

including fiber core diameter, fiber outer diameter, fiber length, maximum transmission power, minimum bending working radius. The subject device is different from the predicate in the connector and laser system compatibility. However, these differences do not raise different questions of safety and effectiveness. The technological differences can be evaluated through the performance testing provided.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 7.

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

# Biocompatibility testing

The biocompatibility evaluation for FLARE™ single-use surgical laser fiber was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation 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 (ISO 10993-5: 2009) ●
- Sensitization - (ISO 10993-10:2010)
- Intracutaneous reactivity - (ISO 10993-10:2010)
- Systemic toxicity - (ISO 10993-11:2017)
- Hemocompatibility (ASTM F756-17)

# Performance testing

Performance testing was conducted on FLARE™ single-use surgical 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 subject device has the same intended use as the laser fibers of the predicate device. The differences between the subject device and the laser fibers of the predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that FLARE™ single-use surgical 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 FLARE™ single-use surgical laser fiber is as safe and as effective as the laser fibers of the predicate device.