Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb

Device Description

The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470mm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.

AI/ML Overview

The Veincare device is intended for the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and incompetent refluxing veins in the superficial venous system in the lower limb.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state "acceptance criteria" for clinical performance. Instead, it details the technical specifications of the Veincare device and compares them to predicate devices to demonstrate substantial equivalence. The non-clinical performance section verifies these technical specifications through bench testing.

Criterion (as defined by technical specifications and non-clinical tests)	Reported Device Performance (Veincare)	Comparison to Predicate Devices & SE Decision
Intended Use	Treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb	Same as Predicate 1, Similar to Predicate 2 (SE: Same as 1, similar to 2)
Principle/Method of Operation	Laser Diode module, power supply, cooling system, optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. Delivers 1470nm laser energy via optical fiber, controlled by foot switch/LCD.	Similar to Predicate 1 and 2 (SE: Same as 1 and 2)
Maximum Power Output	0.5~15W	Same as Predicate 1 (15W), similar to Predicate 2 (1~15W) (SE: Same as 1 and 2)
Wavelength	1470nm	Same as Predicate 1 (1470nm), same as Predicate 2 (1470nm) (SE: Same as 1 and 2)
Pulse Repetition	1Hz~500Hz	Predicate 1: Up to 2000Hz, Predicate 2: 0.2 Hz ~ 50Hz (SE: Similar to 1 and 2, does not affect safety and efficacy)
Pulse Duration	0.2ms ~ 800ms	Predicate 1: Up to 10,000ms, Predicate 2: 10ms ~ 2500ms (SE: Similar to 2, does not affect safety and efficacy)
Mode of Operation	CW, pulsed, Group pulsed	Predicate 1: CW, pulsed, Predicate 2: CW, single pulse, repeat pulse (SE: Same as 1 and 2)
Electrical Safety	Compliant with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2	Verified through non-clinical testing.
Electromagnetic Compatibility (EMC)	Compliant with IEC 60601-1-2	Verified through non-clinical testing.
Software Validation	Designed and developed according to a software development process, verified and validated (MODERATE level of concern software).	Verified through non-clinical testing.
Biocompatibility	Optical fiber component received prior 510(k) clearance (e.g., K232106), thus no additional testing was deemed necessary.	Verified through non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance:

The document states, "No clinical studies were considered necessary and performed." Therefore, there is no test set in the traditional sense of patient data. The evaluation was based on non-clinical (bench) testing of the device's technical specifications and comparison to legally marketed predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable, as no clinical test set was used and therefore no ground truth was established by experts for such a set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The Veincare is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable, as the Veincare is a medical device for treatment, not a standalone algorithm. The "standalone" performance here refers to the device's physical and functional performance, which was evaluated through non-clinical bench tests.

7. The Type of Ground Truth Used:

For the comparisons concerning technical specifications, the "ground truth" is established by the specifications of the legally marketed predicate devices and by international standards (e.g., IEC standards for electrical safety, EMC). For the device's own performance, the "ground truth" is its measured performance per internal design specifications during bench testing.

8. The Sample Size for the Training Set:

Not applicable. This device does not have a "training set" in the context of an AI/machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

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November 14, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Wontech Co., Ltd. Hyunsik Yoon Regulatory Affairs Team General Manager 64 Techno 8-Ro, Yuseong-Gu Daejeon, 34028 Korea. South

Re: K241930

Trade/Device Name: Veincare 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: July 1, 2024 Received: July 1, 2024

Dear Hyunsik Yoon:

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/cdrb/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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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 (QS) 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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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).

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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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

TANISHA L.
HITHE -S
FD
Digitally signed by TANISHA
L. HITHE-S
Date: 2024.11.14 21:45:34
-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

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Indications for Use

510(k) Number (if known) K241930

Device Name Veincare

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/4/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is orange, while the "TECH" part is gray.

510(k) Summary (K241930)

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

November 6, 2024

2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]

Name of Manufacturer: WON TECH Co., Ltd.
Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028, Republic of Korea - Contact Name: Hyun Sik Yoon - Telephone No.: +82 42 934 6800 - Fax No.: +82 42 934 9491 - Email Address: regulatory@wtlaser.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Common name: Surgical Diode Laser System Trade name: Veincare

Classification Description	21 CFR Section	Product Code
Laser surgical instrument for use in general andplastic surgery and in dermatology	878.4810	GEX

As stated in 21 CFR, parts 878.4810, this generic type of devices has been classified as Class II.

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

The identified predicate devices within this submission are shown as follow:

Predicate device 1

• 510(k) Number:	K181632
• Applicant:	Quanta System Spa

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Image /page/5/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is orange, while the "TECH" part is gray.

64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea

TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491 Classification Name: Laser surgical instrument for use in general and plastic surgery and ● in dermatology

Trade Name: VenaCure 1470 Pro ●
Predicate device 2

• 510(k) Number:	K160549
• Applicant:	Wuhan Gigaa Optronics Technology Co., Ltd.
• Classification Name:in dermatology	Laser surgical instrument for use in general and plastic surgery and
• Trade Name:	VELASII-15D

5. Description of the Device [21 CFR 807.92(a)(4)]

Statement of intended use [21 CFR 807.92(a)(5)] 6.

The Veincare is intended for use in the treatment of varicosties with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb

7. Summary of Technological Characteristics [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences between the Veincare and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.

	Proposed Device	Predicate Device 1	Predicate Device 2	SE Decision
K Number	-	K181632	K160549	-
Manufacturer	WON TECH Co., Ltd.	Quanta System Spa	Wuhan Gigga OptronicsTechnology Co., Ltd.	-
Model	Veincare	VenaCure 1470 Pro	Medical Diode Laser System	-
IntendedUse	Veincare is intended for use inthe treatment of varicose veinsand varicosities with superficialreflux of the Greater Saphenous	intended for use in the treatment ofvaricose veins and varicosities withsuperficial reflux of the GreaterSaphenous Vein, and in the	Indicated for the treatment ofreflux of the saphenous veinsassociated with varicose veinsand varicosities	Same as 1,similar to 2

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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the word "WON" in orange and "TECH" in gray. The "W" in the circle is made up of three curved lines that resemble flames.

	Proposed Device	Predicate Device 1	Predicate Device 2	SE Decision
	Vein, and in the treatment ofincompetent refluxing veins inthe superficial venous system inthe lower limb	treatment of incompetent refluxingveins in the superficial venoussystem in the lower limb
Principle/Method ofOperation	The Veincare laser systemconsists of a Laser Diodemodule, a power supply and acooling system. The laser diodemodule consists of an opticalsensor interface, fiber connectorfor high power SMA fiber,protective glass holder,monitoring interface, cathodeand anode. The system deliverslaser energy at a wavelength of1470nm. The output of the laseris delivered to the area oftreatment through an optical fibercable a trigger (Foot switch)controls the delivery of pulses.The user selects the desiredenergy density and enables ordisables the laser at the touchedLCD panel.	The VenaCure 1470 Pro is a diodelaser system emitting at 1470 nmwavelength, with maximum outputpower 15 W. Only the use ofoptical fibers manufactured byAngioDynamics (provided withRFID tag with proprietary internalcode) is allowed with the Anyother use is forbidden.The front panel of the deviceincludes the touch screen display,the optical fiber connector (SMA905) with the RFID antenna, theexternal protection shutter and thesliding knob. On the rear panel thefootswitch connector, the keyswitch, the remote interlock andthe main switch are located. Theemergency stop button is on theupper part of the device	The medical diode lasersystems for this unit is GaAlAsdiode bar, and the wavelengthis 1470nm of VELASII-15D. Itfeatures impact structure, highefficiency and long lifetime.The beam divergence angle istoo large lead to poor beamquality. In order to better meetthe needs of Laser Diodepractical applications, LaserDiode carried beam shaping isvery necessary. With theGIGAA'S unique fiber-coupling technology, the laserbeam can be coupledefficiently into the fiber.	Same as 1and 2
MaximumPowerOutput	0.5~15W	15W	1~15W	Same as 1and 2
Wavelength	1470nm	1470nm	1470nm	Same as 1and 2
PulseRepetition	1Hz~500Hz	Up to 2000Hz	0.2 Hz ~ 50Hz	Similar to 1and 2, doesnot affectsafety andefficacy
Pulseduration	0.2ms ~ 800ms	Up to 10,000ms	10ms ~ 2500ms	Similar to 2,does notaffect safetyand efficacy
Mode ofOperation	CW, pulsed, Group pulsed	CW, pulsed	CW, single pulse, repeat pulse	Same as 1and 2

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Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray.

Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

Electrical Safety, Electromagnetic Compatibility Testing

Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

· IEC 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety

· IEC 60601-1-6 Edition 3.1 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance

Medical electrical equipment - Part 2-22: Particular requirements for basic • IEC 60601-2-22:2007/A:2012 safety and essential performance

• IEC 60825-1 Edition 3.0 2014 Safety of laser products - Part 1: Equipment classification, and requirements

• IEC 60601-1-2:2014/A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perform

2) Software Validation

The Veincare contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.

The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.

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Image /page/8/Picture/0 description: The image shows the Wontech logo. The logo consists of an orange circular icon with a stylized "W" inside, followed by the word "WONTECH". The "WON" part of the word is in orange, while the "TECH" part is in gray.

3) Biocompatibility

The part of the device that comes into contact with the human body is the optical fiber. However, the optical fiber that is a component of the device has received 510(k) clearance beforehand (e.g., K232106). Therefore, no additional biocompatibility test report is needed.
1. Performance Testing

The performance of the Veincare has been defined as follows.

-Laser wavelength: 1470nm
Laser output power: 0.5 to 15 W -
-Pulse /duration: Pulse mode: (0.2 to 800)ms
- Group pulse mode: (0.2 to 800)ms CW mode: CW
-Pulse frequency: 1-500Hz

Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

Conclusion [21 CFR 807.92(b)(3)]

In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd. concludes that the Veincare is substantially equivalent to predicate devices as described herein.

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.