Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELAS II-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. To start the laser unit, turn the main switch ON and turn the key switch clockwise to "I" position. The power indicator will turn green immediately with the system fans working. At the same time, the LCD screen lights up. After the parameters setting is finished, press the "Ready" button and the system will remind you to wear the protective eyewear (protective wavelength is from 800nm to 1700mm). At this time when you press down the footswitch, the laser will emit.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a Medical Diode Laser System (VELAS II -15D). It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining specific performance acceptance criteria for the novel device itself.

Therefore, the document does not explicitly state specific acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, sensitivity, specificity) for the device's clinical efficacy in treating reflux of saphenous veins. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, meaning the new device should perform as safely and effectively as the predicate.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing performed to demonstrate adherence to relevant safety and performance standards, and a comparison presented in the "Summary of Substantial Equivalence" table.

Here's an analysis based on the information provided, though it will not contain specific performance metrics for clinical efficacy as none are present.

1. Table of Acceptance Criteria and the Reported Device Performance

As specific clinical performance acceptance criteria (e.g., success rate of vein closure, reduction in vein diameter) are not provided in this regulatory submission for the novel device, the "acceptance criteria" are inferred from the comparison to the predicate device, primarily focusing on technical specifications and safety standards.

Acceptance Criterion (Inferred from Substantial Equivalence)	Reported Device Performance (VELAS II -15D)
Indications for Use	"The 'VELAS II -15D' is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities."
Laser Type	Diode laser
Wavelength	$1470nm \pm 10nm$
Output power	1-15W
Operation mode	CW, single pulse, repeat pulse
Pulse width	10ms-2.5s
Pulse repetition rate	0.2Hz-50Hz
Application / Light delivery system	Recommended disposable sterile fiber (K124003, MED-Fibers, Inc.), bare fiber, 3m, 600μm fiber core diameter, NA ≥0.22, SMA905 connector, single use.
Aiming Beam	Diode laser of 635/532nm, power max. < 5mW, adjustable brightness.
Laser Class	4
Operation interface	Color LCD touch screen
Power Supply	100-240VAC, 50/60Hz, 350VA
Safety classification	Class I Type B
Waterproof level	IPX1 (device) / IPX8 (footswitch)
Standards Compliance	IEC60601-1, IEC60601-1-2, IEC60601-2-22, IEC60825-1, FDA Guidance for Software.
Non-sterile	Fiber is sterilized by EO.
Microprocessor Control	Yes
Substantial Equivalence Conclusion	"The proposed device of VELAS II -15D has the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device."

Comparison to Predicate (K082225):

Indications for Use: Same.
Laser Type: Same.
Components: Similar (Proposed device does not equip with fiber and handpiece initially, but recommends a specific disposable fiber set; predicate includes these components directly). The submission argues this does not affect safety and effectiveness.
Wavelength: Similar ($1470nm \pm 10nm$ vs $1470nm \pm 30nm$). Proposed device has better accuracy.
Output power: Same (1-15W).
Operation mode: Same (CW, single pulse, repeat pulse).
Pulse width: Similar (10ms-2.5s vs 0.01s-60s). Proposed device's range is contained within the predicate, deemed sufficient for intended use.
Pulse repetition rate: Similar (0.2Hz-50Hz vs 0.01Hz-50Hz). Deemed not to affect safety and effectiveness.
Application / Light delivery system: Similar. Proposed device is more detailed, fiber core diameter range is contained within predicate's general description, deemed sufficient for intended use.
Aiming Beam: Similar. Proposed device's power range contains predicate's, deemed sufficient for intended use.
Laser Class: Same (4).
Operation interface: Same (Color LCD touch screen).
Power Supply: Similar (350VA vs 450VA). Rated power difference not affecting safety and effectiveness.
Safety classification: Same (Class I Type B).
Dimensions & Weight: Similar, proposed device is bigger and heavier. Not noted to affect safety or effectiveness.
Waterproof level: Same (IPX1 device, IPX8 footswitch).
Standard Compliance: Same listed standards.
Non-sterile: Same (Fiber sterilized by EO).
Microprocessor Control: Same (Yes).

2. Sample size used for the test set and the data provenance

The document specifies non-clinical tests (compliance with standards) and software verification. It does not describe a clinical study or a test set in the sense of patient data. Therefore, information regarding "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) is not applicable or not provided in this regulatory submission, which focuses on substantial equivalence based on technical specifications and international standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no clinical test set/study is described, the concept of establishing ground truth by experts is not applicable or not provided in this document. The "ground truth" for the device's technical specifications and safety is established by adherence to international standards and internal quality assurance procedures, as overseen by the manufacturer's technical staff and verified through testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set or study requiring adjudication is described.

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. This device is a surgical laser system, not an AI-assisted diagnostic tool or an imaging device involving "human readers." No MRMC study was mentioned or required for this type of submission.

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

Not applicable. This device is a laser surgical instrument, meaning it inherently has a "human-in-the-loop" (the surgeon) performing the procedure. No standalone algorithm performance is relevant or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the technical performance aspects, the "ground truth" relies on:

International standards compliance: Demonstrated by testing against IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
Software verification: According to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Predicate device's established safety and effectiveness: The core of the 510(k) submission is to argue that the new device is "substantially equivalent" to an already approved predicate device, implying its "ground truth" for safety and effectiveness is comparable to that of the predicate, which has presumably demonstrated its clinical efficacy through other means (e.g., initial clinical trials for its approval, or long-standing safe use).

No specific clinical "outcomes data" or "expert consensus" related to a new discrete clinical study for this specific device is provided in the document.

8. The sample size for the training set

Not applicable. This submission concerns a physical medical device (laser system), not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/machine learning model described.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 7, 2017

Wuhan Gigaa Optronics Technology Co., Ltd Nie Xinxing Regulation Control Manager 5, 6/F, Unit A, B, Building B8, Hi-tech Medical Device Industrial Park, #818 Gaoxin Avenue East Lake Development Zone, Wuhan, 430206 CN

Re: K160549

Trade/Device Name: Medical Diode Laser Systems 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: February 27, 2017 Received: March 6, 2017

Dear Nie Xinxing:

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. 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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160549

Device Name Medical Diode Laser Systems

Indications for Use (Describe)

The "VELASI -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

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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Section 5 - 510(k) Summary

Date of Summary Preparation: February 22, 2016 Date of Summary Revision: February 27, 2017

1. Submitter's Identifications

Submitter's Name: Wuhan Gigaa Optronics Technology Co., Ltd Address: 5, 6/F, Unit A, B, Building B8, Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development Zone, Wuhan 430206,China Contact Person: Nie Xin xing Contact Email Address: fdagigaalaser(@sohu.com Telephone: +86-27-67848871-8045 Fax: +86-27-67848873

2. Correspondent's Identifications

Correspondent's Name: Wuhan Gigaa Optronics Technology Co., Ltd Address: 5, 6/F, Unit A, B, Building B8, Hi-Tech Medical Device Industrial Park, #818 Gaoxin Avenue, East Lake Development Zone, Wuhan 430206, China Contact Person: Nie Xinxing Contact Email Address: fdagigaalaser(@sohu.com Telephone: +86-27-67848871-8045 Fax: +86-27-67848873

3. Name of the Device

Device Classification Name: POWERED LASER SURGICAL INSTRUMENT Product Name: POWERED LASER SURGICAL INSTRUMENT Trade Name: Medical diode laser systems Model: VELAS II -15D Classification Panel: General & Plastic Surgery Product Code: GEX Device Classification: Class II

4. The Predicate Devices

K082225 15W Ceralas D 1470nm Diode Laser, D1470

5. Device Description

Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.

The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELAS II-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser

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Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.

To start the laser unit, turn the main switch ON and turn the key switch clockwise to "I" position. The power indicator will turn green immediately with the system fans working. At the same time, the LCD screen lights up.

After the parameters setting is finished, press the "Ready" button and the system will remind you to wear the protective eyewear (protective wavelength is from 800nm to 1700mm). At this time when you press down the footswitch, the laser will emit.

6. Intended Use of Device

Intended Use of Medical Diode Laser Systems "VELAS II -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

7. Summary of Substantial Equivalence

	Proposed Device	Predicate device	Comparison
510k Number	-------	K082225	-------
Product Code	GEX	GEX	Same
ProprietaryName	Medical Diode LaserSystems	15W Ceralas D 1470nmDiode Laser	-------
Model	VELAS II -15D	D1470	-------
Manufacturer	Wuhan Gigaa OptronicsTechnology Co., Ltd	Biolitec, Inc.	-------
Indications foruse	The "VELAS II -15D" isindicated for use in thetreatment of reflux ofthe saphenous veinsassociated with varicoseveins and varicosities.	The device is indicatedfor the treatment ofreflux of the saphenousveins associated withvaricose veins andvaricosities.	Same
Laser Type	diode laser	diode laser	Same
Components	Laser system, Colortouch screen, Footswitch, Power detector	Laser system, Colortouch screen, Fiber andthe handpiece, Footswitch, Power detector	Similar.Handpiece in D1470 asthe laser transmissionsystem used withoptical fiber together.VELAS II -15D doesnot equip with fiber andhandpiece, butrecommending a

			disposable sterile fiber(K124003,MED-Fibers, Inc.)registered in U.S.A, notaffect the safety andeffectiveness.
Wavelength	$1470nm\pm10nm$	$1470nm\pm30nm$	Similar.Center wavelength isconsistent, andwavelength accuracy ofVELAS II -15D is betterthan that of thepredicate device.
Output power	1-15W	1-15W	Same
Operation mode	CW, single pulse, repeat pulse	CW, single pulse, repeat pulse	Same
Pulse width	10ms-2.5s	0.01s -60s	Similar.Pulse width range of thedevice is contained inthat of the predicatedevice, and it has beendesigned to meet theintended userequirement claimed.
Pulse repetition rate	0.2Hz-50Hz	0.01Hz-50Hz	Similar.Pulse repetition rate isslight similar, not affectsafety and effectiveness.
Application /Light deliverysystem	It is recommended touse the disposablesterile fiber (K124003,MED-Fibers, Inc.)registered in U.S.A.The parameters mustmeet the followingrequirements:• bare fiber, long as 3m• Fiber core diameter:600μm• NA ≥0.22• With SMA905connector• Single used	Fiber diameter ≥ 360μm	Similar.VELAS II -15D isdescribed more detailed.Fiber core diameterrange of VELAS II -15Dis contained in that ofthe predicate device,and it has been designedto meet the intended userequirement claimed.
Aiming Beam	Diodelaser of635/532nm, power max.< 5mW, adjustablebrightness.	532nm and 635nm,green 1mW, red 4 mW,user controlled intensity	Similar.Aiming beam powerrange of VELAS II -15Dcontains that of thepredicate device, and ithas been designed tomeet the intended userequirement claimed.
Laser Class	4	4	Same
Operationinterface	Color LCD touch screen	Color LCD touch screen	Same
Power Supply	100-240VAC, 50/60Hz,350VA	220-240 VAC, 50/60Hz,450VA	Similar.Only rated power isdifferent, not affectsafety and effectiveness.
Safetyclassification	Class I Type B	Class I Type B	Same
Dimensions	400(W)385(L)200(H)mm	370(W)90(L)280(H)mm	Similar.VELAS II -15Disbiggerthanthepredicate device.
Weight	12.9kg	8.5kg	Similar.VELAS II -15Disheavierthanthepredicate device.
Waterprooflevel	IPX1	IPX1	Same
FootswitchWaterprooflevel	IPX8	IPX8	Same
Standard	IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1	IEC60601-1IEC60601-1-2IEC60601-2-22IEC60825-1	Same
Non- sterile	Fiber is sterilizedbyEO.	Fiber is sterilizedbyEO.	Same
MicroprocessorControl	Yes	Yes	Same

Table 1

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Wuhan Gigaa Optronics Technology Co., Ltd

8. Substantial Equivalence:

The proposed device of VELAS II -15D has the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device.

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Wuhan Gigaa Optronics Technology Co., Ltd

The differences only exist in such contents: component of handpiece that do not influence use even if without it, wave rang of wavelength, output power, pulse width, pulse repetition rate and aiming beam that all can be controlled in range of application. These differences are slight and do not influence the effectiveness and safety of the device. According to the non-clinical and clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed devices are Substantially Equivalent (SE) to the predicate device which is US legally market device.

9. Non-Clinical Tests Performed:

The following testing was performed on the "VELAS II-15D" Medical Diode Laser Systems in accordance with the requirements of the design control regulations and established quality assurance procedures.

IEC60601-1:2005+A1:2012+National differences of US ANSI/AAMI Medical electrical equipment-Part 1: General requirements for basic safety and essential performance Incorporates Amendment 1:2012; Incorporates National differences of US ANSI/AAMI

ES60601-1:2005+C1:2009+A2:2010+A1:2012 Medical equipment-Part 1: General requirements for basic safety and essential performance Consolidated reprint C1:2009; Incorporates Amendment 2:2010; Incorporates Amendment 1:2012

IEC60601-2-22:2007+A1:2012 Medical electrical equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Incorporates Amendment 1:2012

IEC60601-1-2:2007 Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility - Requirements and tests

IEC60825-1:2007 Safety of laser products-Part 1: Equipment classification and requirements In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

10. Conclusion:

The proposed devices of VELAS II-15D is determined to be Substantially Equivalent (SE) to the predicate device, 15W Ceralas D 1470nm Diode Laser, D1470 in respect of safety and effectiveness.

--- End of this section ---

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.