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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, the FLARE™ single-use surgical laser fiber. It details the device's characteristics, intended use, and comparison to a predicate device.

However, the document does not contain information about a study that assesses a device's performance against specific acceptance criteria in the context of an AI/human-in-the-loop study, or a standalone algorithm performance study.

The "Performance testing" section on page 6 states: "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."

This statement refers to engineering and material performance tests (e.g., optical properties, mechanical strength, dimensions, shelf life) of the laser fiber itself, not a clinical study involving human readers or AI for diagnostic or interpretative tasks. Therefore, the detailed information requested in the prompt (acceptance criteria for a clinical study, sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth establishment for AI/diagnostic performance) is not present in this document.

In summary, the provided document does not contain the information needed to answer the prompt's specific questions regarding acceptance criteria and a study proving device performance related to diagnostic accuracy, human-in-the-loop performance, or AI algorithms. The "performance testing" described is for the physical and functional aspects of the laser fiber for its intended surgical application, not for a diagnostic or AI-assisted interpretation task.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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: +86-512-62868599

Primary Contact	Olivia Meng
Person:	Regulatory Affairs Manager
	Guangzhou Osmunda Medical Device Technical ServiceCo., Ltd.
	Tel: (+86)-20-6231 6262
	Fax: (+86) -20-8633 0253
Secondary Contact	Mingzhu Liu
Person:	Quality Manager
	Realton (Suzhou) Medical Technology Co., Ltd.
	Tel: (+86)-512-62868599
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, RLT365-730L1, RLT550L1, RLT600L1, RLT760L1, RLT940L1,RLT105S1, RLT200S1, RLT272S1, RLT365-550S1, RLT365-730S1, RLT550S1, RLT600S1, RLT760S1, RLT940S1
Regulation number	21 CFR 878.4810
Regulation Class:	II
Product Code:	GEX Powered Laser Surgical Instrument

1. PREDICATE DEVICE
  SlimLine™ Family of Delivery Fibers, K170121

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DEVICE DESCRIPTION 4.

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 ofdifference
Trade name	FLARETM single-use surgicallaser fiber	Lumenis Family of Holmium SurgicalLasers and Delivery Devices andAccessories (VersaPulsePowerSuite, Lumenis Pulse 30H,Lumenis Pulse 50H, Lumenis Pulse60H, Lumenis Pulse 100H andLumenis Pulse 120H)	NA
Device name	FLARETM single-use surgicallaser fiber	SlimLineTM Family of Delivery Fibers	NA
Manufacturer	Realton (Suzhou) MedicalTechnology Co., Ltd.	Lumenis Ltd.	NA
510 (k)number	K202702	K170121	NA
Product code	GEX	GEX	Same
Intended use	FLARETM single-use surgicallaser fiber is intended to beused to deliver the laserradiation to the target tissuewhen used with compatiblesurgical lasers with operationalwavelength between 532 nm-2140 nm and equipped withSMA 905 compatible	Lumenis SlimLine fiber are intendedfor use with compatible lasers insurgical procedures involving open,laparoscopic, and endoscopicablation, vaporization, excision,incision, coagulation of soft tissueand for lithotripsy.	Similar
			R202702
	connector.FLARE™ single-use surgicallaser fiber is indicated for usein general surgical applicationsfor open, laparoscopic, andendoscopic ablation,vaporization, excision, incision,coagulation of soft tissue andfor lithotripsy.
	Contraindications	Refer to the laser operator'smanual for contraindicationsthat may be specific to eachspecialty.		Refer to the laser operator'smanual for contraindications thatmay be specific to each specialty.	Same
	Prescription orOTC	Prescription		Prescription	Same
	Components	The device is mainly composedof connector and bare fiber.Protective sleeve is around thebare fiber.		The fiber consists of a laserconnector and a glass fiber.	Similar
	Material offiber	Fused quartz		Fused quartz	Same
	Fiber corediameter(μm)	105, 200, 272, 365, 550, 600,760, 940		272, 365, 550, 940	Similar
	Fiber outerdiameter(mm)	0.25, 0.40, 0.42, 0.55, 0.73,0.75, 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
	Applicablewave lengths	532nm~2140nm		532nm~2140nm	Same
Maximumtransmissionpower	20 W, 100W, 120 W	15W, 45W, 120W	Similar
Minimumbendingworking radius(mm)	12, 20, 24	12, 14, 20, 24	Similar
Connector	SMA-905 standard opticalconnector	Secure identification system	Different
Laser systemscompatibility	Applied to lasers withwavelengths from 532 nm to2140 nm.	VersaPulse™ PowerSuite™ SingleWavelength HorimiumVersaPulse PowerSuite DualWavelengthVersaPulse P20Lumenis 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.

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.