(163 days)
Not Found
No
The 510(k) summary describes a surgical laser fiber, a passive device for delivering laser energy. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on material properties and physical performance, not algorithmic performance.
Yes
The device is described as being used for "ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy," which are therapeutic applications.
No
The device is a surgical laser fiber intended for delivering laser radiation for ablation, vaporization, excision, incision, coagulation of soft tissue, and lithotripsy, which are therapeutic rather than diagnostic applications.
No
The device is a physical surgical laser fiber, not a software application. The description details hardware components (optical fiber, connector) and physical processes (sterilization, laser energy delivery).
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 used to "deliver the laser radiation to the target tissue" for surgical procedures like "ablation, vaporization, excision, incision, coagulation of soft tissue and for lithotripsy." This describes a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a surgical laser fiber that outputs laser energy for "laser operation." This further reinforces its role in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver energy for surgical treatment.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Conclusion: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
1
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)
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) | |
|---|---|
| ✘ 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 Service | |
| Co., 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 |
-
- PREDICATE DEVICE
SlimLine™ Family of Delivery Fibers, K170121
- PREDICATE DEVICE
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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
difference | | |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------------------------------------------------------------------------------------------------------|---------|
| Trade name | FLARETM single-use surgical
laser fiber | Lumenis Family of Holmium Surgical
Lasers and Delivery Devices and
Accessories (VersaPulse
PowerSuite, Lumenis Pulse 30H,
Lumenis Pulse 50H, Lumenis Pulse
60H, Lumenis Pulse 100H and
Lumenis Pulse 120H) | NA | | |
| Device name | FLARETM single-use surgical
laser fiber | SlimLineTM Family of Delivery Fibers | NA | | |
| Manufacturer | Realton (Suzhou) Medical
Technology Co., Ltd. | Lumenis Ltd. | NA | | |
| 510 (k)
number | K202702 | K170121 | NA | | |
| Product code | GEX | GEX | Same | | |
| Intended use | 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 nm and equipped with
SMA 905 compatible | Lumenis SlimLine fiber are intended
for use with compatible lasers in
surgical procedures involving open,
laparoscopic, and endoscopic
ablation, vaporization, excision,
incision, coagulation of soft tissue
and for lithotripsy. | Similar | | |
| | | | R202702 | | |
| | 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. | | | | |
| | Contraindications | Refer to the laser operator's
manual for contraindications
that may be specific to each
specialty. | | Refer to the laser operator's
manual for contraindications that
may be specific to each specialty. | Same |
| | Prescription or
OTC | Prescription | | Prescription | Same |
| | Components | The device is mainly composed
of connector and bare fiber.
Protective sleeve is around the
bare fiber. | | The fiber consists of a laser
connector and a glass fiber. | Similar |
| | Material of
fiber | Fused quartz | | Fused quartz | Same |
| | Fiber core
diameter
(μm) | 105, 200, 272, 365, 550, 600,
760, 940 | | 272, 365, 550, 940 | Similar |
| | Fiber outer
diameter
(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 |
| | Applicable
wave lengths | 532nm2140nm | | 532nm2140nm | Same |
| Maximum
transmission
power | 20 W, 100W, 120 W | 15W, 45W, 120W | Similar | | |
| Minimum
bending
working radius
(mm) | 12, 20, 24 | 12, 14, 20, 24 | Similar | | |
| Connector | SMA-905 standard optical
connector | Secure identification system | Different | | |
| Laser systems
compatibility | Applied to lasers with
wavelengths from 532 nm to
2140 nm. | VersaPulse™ PowerSuite™ Single
Wavelength Horimium
VersaPulse PowerSuite Dual
Wavelength
VersaPulse P20
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.