The VeinGogh instrument is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation. Users could wear a magnification aid to ensure adequate vision of the treatment area. The user could wear a face shield and gloves as indicated by office practices. The user inserts the needle point in a telangiectasia at a right angle to the vein after setting the instrument's control panel setting of time and pulse or using the instrument's Auto-Pulse functionality. Pulses are intended to be created every 2-3 mm along a vein. The user should clean the needle point frequently between vein insertions with a sterile compress.

The instrument's regulated, small, high frequency current is delivered to the vessel, in a process called "Ohmic Thermolysis," during which the electrical resistivity selectively thermocoagulates small blood vessels using microbursts of high-frequency electrical energy delivered into the vessel. This Microburst Technology™ of fixed amplitude energy within the vessel is converted to heat instantly, coagulating the blood and collapsing the vessel wall. The pulse train encompasses sharp, precise peaks to minimize the risk of damage and deliver consistent results.

The high frequency current is delivered into each vessel through the sterile needle as positioned and inserted by the medical professional. Trained medical professionals can deliver fast, immediate results, which are consistent and repeatable, with little or no discomfort to the patient.

Experienced medical professionals can treat vessels up to 0.3 mm throughout the body. Typically, only a single treatment is required. Multiple spider veins or telangiectasias are treated subepidermally along each veins length, typically every 2-3 mm.

The instrument has a foot switch that is used to cause the instrument to send one pulse with each pressing of the switch. The instrument also has a Ballet Needle holder and uses single use Ballet K3 and K2 stainless steel and gold needles, which are not intended for reuse. The instrument is designed to accommodate needle holders and needles which are equivalent to Ballet Needle Holders and Needles, specifically, those products having the same or similar labeling and listed by their manufacturer under the same regulation and product code.

The instrument has firmware that interacts with the Control Panel push buttons to provide the professional user with operational controls. The firmware cannot be edited or changed by the user.

No bandage or other treatment of the thermocoagulated area is required. Typical treatment times are under 20 minutes and the treatment area (40-50 cm) may receive 300 to 600 impulses during a treatment.

The instrument is not designed to treat feeder vessels or larger vessels deep beneath the skin's surface.

The instrument's dimensions, 16.1 in wide x 13 inches deep x 5.9 inches high and weight, 5.7 pound, allow the device to be used in small or large medical offices on any convenient flat surface. The instrument is intended to be moved in a safe and effective manner, such as movement from one room to another in a medical office or clinic environment.

The instrument is powered by a grounded 120 Volt power source from a wall or floor electrical receptacle. The electrical components are intended to be safe and effective and easily accessed by a qualified technician for any appropriate replacement or repair.

The VeinGogh instrument has a 4MHz frequency wave output, and a maximum voltage output of 205Vpp +/-10%.

Microburst Technology is a Trade Mark of Refine USA, LLC, Jacksonville Beach, FL

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VeinGogh™ instrument. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical trial to establish new safety and effectiveness. Therefore, the document does not present "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the way one might expect for a novel device undergoing extensive clinical efficacy testing.

Instead, the submission aims to show that the VeinGogh™ instrument is as safe and effective as its predicate device (Veinwave/TC3000) by demonstrating identical intended use and largely similar technological characteristics, and addressing any differences through non-clinical testing.

Here's an analysis of the provided information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" for performance are primarily based on demonstrating equivalence to the predicate device's characteristics and meeting relevant safety standards. The performance is reported through a comparative table and non-clinical testing summaries.

Characteristic/Function	Acceptance Criteria (Predicate)	Reported Device Performance (VeinGogh™)
Intended Use	Thermocoagulation for lower limb spider vein or telangiectasia	Thermocoagulation for lower limb spider vein or telangiectasia (Identical)
Design Specifications	Similar to submitted device	Similar to predicate device (Equivalent)
Classification Name, Number & Product Code	Same as submitted device	Same as predicate device (Identical)
Operational Environment	Same as submitted device	Same as predicate device (Identical)
Electrical Safety (Certification)	Not referenced in 510(k) Summary for predicate	Certified to IEC 60601-2-2, 5th Ed., 2009-02 (Claimed improvement over predicate)
Flammability Testing	No claim made	Passed UL 94 Flammability testing (Claimed improvement over predicate)
Power Supply	In-house designed - 100V Output	OTS Medical Rated Astrodyne MKK 40D-24 (24V Output) (Claimed as safe or safer)
Isolation Capacitor in Series with Treatment Connection	Yes	Yes (Identical)
High Voltage Rated "Y" Type Capacitor	Yes, Y-Type	Yes, Y-Type (Identical)
Number of Capacitors	Single	Dual (Claimed greater failure protection)
Capacitor Used	22nF (~20x leakage)	1.1nF
Typical Maximum Output Voltage	500 V Maximum	205 V Maximum (+/-10%) (Claimed greater safety)
Output Waveform Frequency	4MHz	4MHz (Identical)
High Voltage Pulse Generator	Yes	Yes (Identical)
Type of Generating Circuit	Fly-back Type	Fly-back Type (Identical)
Range of Peak to Peak Pulse Amplitude	80Vpp to 502Vpp	98Vpp to 205Vpp (+/-10%) (Claimed greater safety)
Output Voltage Increases at Low Settings	Yes (with noticeable dip)	No (Output voltage increases throughout useful range)
Number of Power Settings	3	14 (Claimed more sophisticated range)
Auto-Pulse Functionality	No auto-pulse functionality	User activated software with adjustable delay (New feature, claimed more efficient)
Other operational controls (e.g., pulse duration, display, reset functions)	Generally "Yes" for predicate	Generally "Yes" for VeinGogh™ (Stated as identical or very similar)

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

The document explicitly states that no animal or clinical testing was deemed necessary because "both the predicate instrument and the submitted instrument have the same indications for use, the same or similar design features and functions." Therefore, there is no "test set" in the sense of patient data.

The "testing" mentioned is non-clinical performance data testing and review, which includes:

Bench testing of major electronic components.
Verification testing of firmware modules.
Validation testing of the finished instrument's intended use, requirements, and hazard mitigation.
Electrical safety testing (conformance to IEC and EN standards).
Plastic flammability testing (conformance to UL 94).

The data provenance is therefore from laboratory bench testing and technical conformance assessments. There is no mention of country of origin for such data, as it's typically internal product development and testing.

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

Given the absence of patient data or clinical studies, there's no "ground truth" derived from expert clinical assessment of patient outcomes in this submission. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601-2-2, EN 60601-1-2, UL 94) and the design specifications of the device. The experts involved would be the engineers and technicians performing the tests and verifying compliance with these standards, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

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

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document states, "The submitter believes that both the predicate instrument and the submitted instrument have the same indications for use, the same or similar design features and functions, which negates a requirement for the submission of animal or clinical testing." This indicates that efficacy was assumed based on equivalence to the predicate, and no human reader/clinician study was performed to assess comparative effectiveness or improvement with AI assistance (as no AI is described).

6. Standalone (Algorithm Only) Performance Study

Not applicable. The VeinGogh™ instrument is a physical electrosurgical device, not an algorithm, and the submission does not describe any AI component.

7. Type of Ground Truth Used

The "ground truth" for this submission are:

Predicate Device Equivalence: The performance and safety profile of the legally marketed Veinwave/TC3000 device.
Engineering and Safety Standards: Conformance to electrical safety standards (IEC 60601-2-2, EN 60601-1-2), EMC standards (EN 55011/CISPR 11), and flammability standards (UL 94).
Device Design Specifications: The stated requirements and design specifications established during the device's development.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, and no software "training set" is mentioned. The firmware is proprietary and developed by a contract supplier, with verification testing performed on its modules.

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

Summary

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K112334 PAGE I OF II

Image /page/0/Picture/1 description: The image shows a logo for "Refine usa". The word "Refine" is written in a cursive font, with the "R" being larger than the other letters. The word "usa" is written in a smaller, sans-serif font and is located below the "ine" in "Refine". The logo is surrounded by an oval shape, with the top and bottom of the oval being slightly thicker than the sides.

Refine USA. LLC 340 3rd Avenue South, Suite C Jacksonville Beach, Florida 32250 (866) 333-6858 FAX (888) 842-0395 Cell (904) 629-0395

510(K) SUMMARY

MAY - 8 2012

In compliance with 21 CFR 807.92(a)(1):

Premarket Notification submitter:

Company Name:	Refine USA, LLC
Company Address:	340 3rd Avenue S., Ste. C, Jacksonville Beach, FL32250

Brian Smith, President Contact:

August 8, 2011 Preparation Date:

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Device Name – as required by 807.92(a)(2):

Vein-Gogh™ instrument Trade Name:

Common/Classification Name: Electrosurgical cutting and coagulation device and accessories

21 CFR 878.4400 Classification Regulation:

Device Class: Class II

Product Code (Procode): ONQ

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LEGALLY MARKETED PREDICATE DEVICE – as required by 807.92(a)(3)

The VeinGogh instrument is substantially equivalent to the presently marketed Veinwave/TC3000 device manufactured by Newlands Clinical Trials, Ltd., Bolton, United Kingdom, and cleared under K083352.

DEVICE DESCRIPTION - as required by 807.92(a)(4)

The instrument's requlated, small, high frequency current is delivered to the vessel, in a process called "Ohmic Thermolysis," during which the electrical resistivity selectively thermocoagulates small blood vessels using microbursts of high-frequency electrical energy delivered into the vessel. This Microburst Technology™ of fixed amplitude energy within the vessel is converted to heat instantly, coagulating the blood and collapsing the vessel wall. The pulse train encompasses sharp, precise peaks to minimize the risk of damage and deliver consistent results.

The instrument has firmware that interacts with the Control Panel push buttons to provide the professional user with operational controls. The firmware cannot be edited or changed by the user.

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No bandaqe or other treatment of the thermocoagulated area is required. Typical treatment times are under 20 minutes and the treatment area (40-50 cm) may receive 300 to 600 impulses during a treatment.

The instrument is not designed to treat feeder vessels or larger vessels deep beneath the skin's surface.

The VeinGogh instrument has a 4MHz frequency wave output, and a maximum voltage output of 205Vpp +/-10%.

Microburst Technology is a Trade Mark of Refine USA, LLC, Jacksonville Beach, FL

INTENDED USE - as required by 807.92(a)(5)

The instrument is intended to be used by physicians, physician's assistants (PA) and other physician staff under the direction of a physician trained in the removal of telangiectasia and spider veins on the lower extremities of adults. The instrument is not intended to be used on children.

TECHNOLOGICAL CHARACTERISTICS - as required by 807.92(a)(6)

The VeinGogh instrument operates in a typical healthcare professional's office from a standard, grounded 120 Volt AC wall or floor receptacle. The instrument can also be provided to operate at 240 V AC.

The instrument has an allowable environmental operating and storage temperature range of 50 – 90°F and a humidity range of 20-80% (without condensation).

The instrument's desktop footprint is approximately 16″ (w) x 13″ (d) x & 5.9″ (h) and weighs 5.7 pounds and is intended to be placed on a sturdy, flat surface convenient to the patient's location.

The instrument's case/exterior finish allows for dusting and disinfecting.

The VeinGogh has a maximum age output of 205 Volts point-to-point ( +/-10%) and a 4MHz wave frequency which is delivered as a pulsed output through sterile high frequency epilator needles and needle holder, (Ballet or

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equivalent). Typically, Ballet K3 or K2 insulated needles are held in a Ballet Needle holder or equivalent needle holder.

The high frequency epilator needle holder, (Ballet or equivalent) specified are single use only and are not intended for reuse.

The Ballet Needles are listed as a Class I instrument, Product Code KCW by their manufacturer, Ballet Technologies, Ltd.

[http://www.balletneedles.com/], 2 Horsebridge Cottages, Horsebridge Common, Ashurst, W. Sussex, UK BN44 3AL, phone +(44) 1903 816 764, Email: Ballet.Technolqies@hotmail.com. Ballet's U.S. distributor is Synoptic Products, 336 Baker Avenue, Concord, MA 01742, phone (978) 287 -728

The VeinGogh instrument has a control panel that interacts with its firmware and allows the operator to control:

Standby/RUN .
Amplitude Power or intensity as a relative % of the nominal 205 Volt ● peak to peak +/-10%
Pulse number .
Auto on .
Auto off .
Time .
Pulse as a range 0.1 second up to 0.8 second .
Reset for resetting the time and number of pulses ●

Overall, the technological characteristics of the VeinGogh instrument are either identical or very similar to the predicate device. The VeinGogh instrument does have a few new technological characteristics not found in the predicate device. These differences are detailed in the "Product Comparison Table," below.

PRODUCT COMPARISON TABLE
Characteristic/Function	Veinwave device(predicate)	VeinGogh Instrument
Intended Use for Device	Thermocoagulation	Thermocoagulation
Design Specifications	Similar to submitted device	Similar to predicate device
Classification Name,Number & Product Code	Same as submitted device	Same as predicate device
Operational Environment	Same as submitted device	Same as predicate device
Performance TestingResults	None referenced in 510(k)Summary	Referenced in 510(k)Summary
Certified to IEC 60101-2-2 Edition 5.0 2009-02Medical ElectricalEquipment Part 2-2	Makes no Claim	Yes
UL 94 Flammabilitytesting	Makes no Claim	Passed
Finished DeviceDimensions - Top	38 x 53 x 17 cm	41 x 33 x 15 cm
Finished DeviceDimensions - Bottom	32 x 32 cm	33 x 27 cm
Finished Device Weight	6.6 kg	2.6 kg
PRODUCT COMPARISON TABLE
Characteristic/Function	Veinwave device(predicate)	VeinGogh Instrument
Finished DeviceConstruction	Bottom section is made ofsteel & the top section ismade from injectionmolded plastic	Enclosure is made fromfiberglass filled resin &internally coated withconductive metallic layerfor EMC protection
Power Supply	In-house designed - 100VOutput	OTS Medical RatedAstrodyne MKK 40D-24(24V Output)
Discrete Power Supply forSafety Isolation	Yes	Yes
Isolation Capacitor inSeries with TreatmentConnection	Yes	Yes
High Voltage Rated "Y"Type Capacitor	Yes, Y-Type	Yes, Y-Type
Capacitor Used	22nF(~20x leakage)	1.1nF
Dual Capacitors	No	Yes - failure protection
Typical Maximum OutputVoltage	500 V Maximum	205 V Maximum (+/-10%)
Output WaveformFrequency	4MHz	4MHz
High Voltage PulseGenerator	Yes	Yes
Type of Generating Circuit	Fly-back Type	Fly-back Type
Return Electrodes	No	No
Patient Isolation fromMains	Internal IsolationCapacitors in Series withthe output signal connector	Internal IsolationCapacitors in Series withthe output signalconnector
Neutral Connection toMains	Yes	Yes
Chassis Connector	4mm Banana-typereceptacle	Identical
Foot Switch	Yes	Yes
Device Console	Proprietary to Device	Proprietary to Device, butsimilar
Embedded ControllerBoard	Yes	Yes
Firmware	Proprietary to Device	Proprietary to Device
LCD Display/Type	Yes/Monochrome	Yes/Color
Start-up "splash" screen	Display's Device name, SWversion	Display's Device Name,SW version
Display Device Logo	Displays VEINWAVE name	Display's VeinGoghName/Logo
Display of "power" of thevoltage wave (Vpp) as a% of Maximum power orvoltage	Yes	Yes
User control of highfrequency pulse as a % ofmaximum	Yes	Yes
	PRODUCT COMPARISON TABLE
Characteristic/Function	Veinwave device(predicate)	VeinGogh Instrument
pulse amplitudeUser controls the pulseamplitude and pulseduration forthermocoagulation	Yes	Yes
Dissipated Power at 100%Output Power with 300mspulse & 1000 Ohm load	1.35W	1.35W
Dissipated Power atTypical Treatment Power,assuming 1000 Ohms	0.66W	0.66W
Range of Peak to PeakPulse Amplitude	80Vpp to 502Vpp	98Vpp to 205Vpp (+/-10%)
Output Voltage Increasesat Low Settings	Yes	No
No user control ormeasurement of power asfound in "electrosurgicaldevices"	Yes	Yes
Relative power settingsfrom 5% to 100%	Yes	Yes
Power setting has a pre-set or default	Yes	Yes
Maximum power settingidentified	Yes	Yes
No claim made to linearityof power setting	Yes	Yes
Testing documents non-linearity of power settings	Yes	Yes
Testing of optimum ordefault setting as Vpp +/-4%	207	205
Testing of lowest statedor recommended as Vpp+/- 4%	144	143
Number of settings basedon the range of powersettings from lowest listedor recommended	3	14
Nearly identical treatmentoutput signals at 100msburst	Yes	Yes
Nearly identical treatmentoutput signals at 200msburst	Yes	Yes
Nearly identical treatmentoutput signals at 400msburst	Yes	Yes
Nearly identicaltreatment output signalsat 800ms burst	Yes	Yes
PRODUCT COMPARISON TABLE
Characteristic/Function	Veinwave device(predicate)	VeinGogh Instrument
Labeling of RelativeOutput Settings &Relative Voltages onDevice & User Manual	No	Yes
Display of pulse durationin 0.1 second	Yes	Yes
Control of pulse durationin 0.1 second increments	Yes	Yes
User reset to zeroseconds	Yes	Yes
Measured pulse shapes atlow Vpp are similar	Yes	Yes
Measured pulse shapes atmedium Vpp are similar	Yes	Yes
Measured pulse shapes athigh Vpp are similar	Yes	Yes
Pre-set or default pulseduration in seconds	0.2	0.2
Range of pulse durationsettings	0.1 second to 0.8 second	0.1 second to 0.8 second
Display of # of pulses intreatment session	Yes	Yes
Pulse activation causes aacoustic "beep" or shortaudio tone	Yes	Yes
Pulse duration displayed	Yes	Yes
Timer display of length oftime device has been in"run" mode	Yes	Yes
Reset timer to zero time	Yes	Yes
Display how many pulsesthe device has performed	Yes	Yes
Reset display of pulses tozero	Yes	Yes
Set "Standby" mode -display current status	Yes, "Off" is their standby	Yes
Set "Run" mode - displaythe current status	Yes	Yes
Auto-Pulse Enable	No auto-pulse functionality	User activated softwarewhich provides the userwith an output pulse with auser defined adjustabledelay between pulses
Auto-Pulse Disable	No auto-pulse functionality	User inactivates softwarefunctionality
Ballet Needle Holder(stylus) Cable and Cord	Yes	Identical
Ballet K3 Needles	Yes	Identical
Ballet K2 Needles	Yes	Identical
Ballet K3/K2 Gold Needles	Yes	Identical

{5}------------------------------------------------

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{8}------------------------------------------------

Discussion of Differences in Characteristics between the VeinGogh Instrument and the Predicate Device

The VeinGogh instrument is certified to IEC 60601-2-2, Edition 5.0 2009-02 Medical Electrical Equipment Part 2-2. The instrument has passed UL 94 Flammability testing. The Submitter believes the electrical safety certification and flammability testing provides users with assurance the VeinGogh instrument is safe to use as specified and as intended.

The VeinGoqh instrument's power supply is an off-the-shelf medical rated Astrodyne MKK 40D-23 24V output device. The predicate's power supply is an inhouse designed with 100V output. The Submitter believes that the VeinGogh instrument's power supply is as safe or safer than the predicate's power supply. The VeinGogh instrument has dual capacitors, while the predicate device has a single capacitor. The Submitter believes that dual capacitors provide the user with greater failure protection.

The VeinGogh instrument's typical maximum output voltage is 205 Volts +/-10%, while the predicate device's maximum output voltage is 500 Volts. The Submitter believes that the lower maximum voltage provides the user with greater safety during treatment sessions.

Both the VeinGogh instrument and the predicate device have proprietary firmware/software.

The VeinGogh instrument has a color LCD display, while the predicate device has a monochrome display. The Submitter does not believe that this difference is significant or provides any significant advantaqe to either device.

The VeinGogh instrument's range of peak to peak pulse amplitudes is 98VPP to 205Vpp, while the predicate device's peak to peak range is 80Vpp to 502Vpp. The Submitter believes that the lower peak to peak amplitude range provides the user with greater safety during treatment sessions.

The VeinGogh instrument's output voltage increases throughout the typical useful range of power settings, while the predicate device has noticeable dip in output voltages for the first setting, 5% and experiences lower output voltages at both 10% and 15%. Both units exhibit either small, similar or identical output voltages at power settings above 80%. The Submitter believes that the predicate's dip in output voltage many not be expected by users of their device.

The VeinGogh instrument has 20 power settings from the lowest listed or recommended to the highest, the predicate device has only 3 power settings from the lowest listed or recommended to the highest recommended settings. The Submitter believes that this greater range of power settings provides the user with a more sophisticated range of output voltages for use during treatment.

The VeinGogh instrument has a user activated software feature called "Auto-Pulse," which can be enabled or disabled. Auto-Pulse provides the user with an output pulse with a user defined adjustable delay between pulses settings. The predicate device has no similar characteristic or feature. The Submitter believes that the Auto-Pulse feature provides users with a more efficient treatment protocol.

{9}------------------------------------------------

NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as required by 807.92(b)(1)

Non-Clinical Testing

The submitted instrument has undergone significant verification and validation testing.

Verification testing included the bench testing of major electronic components of the instrument.

The firmware was developed by a contract supplier who has provided the firmware specifications requirements document and other firmware documentation. Firmware modules were subjected to verification testing.

Validation testing included testing of the finished instrument's intended use, requirements and confirmation that all identified hazards have been either eliminated or mitigated to an acceptable level.

The performance data records documents that the VeinGogh instrument met its stated requirements and design specifications as intended.

Animal and Clinical Testing

The submitter believes that both the predicate instrument and the submitted instrument have the same indications for use, the same or similar design features and functions, which negates a requirement for the submission of animal or clinical testing. Those few characteristics that the submitted instrument has that are not found in the predicate device are typically the result of the interaction with potential users and their desire for functionality that improves their use of this technology and are not significant differences.

Electrical Safety Testing

The submitter claims and documents conformance to:

1. IEC 60601-2-2, 4th Edition, 2006, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
1. EN 60601-1-2:2007/IEC 60601-1-2:2007 (Medical Electrical Equipment - collateral standard: electromagnetic compatibility - requirements.
1. EC 60601-2-2:2006 Medical Electrical Equipment Particular requirement for the safety of high frequency surgical equipment - (EMC testing only)
1. EN 55011:2007/A2:2007/CISPR 11:2003, Group 2, Class B, 2 pages.

Plastic Flammability

The submitter claims and documents conformance to UL 94 Tests for Flammability of Plastic Materials for Parts in Instruments and Appliances, Fifth Edition, Dated October 26, 1996; including revisions through October 21, 2010.

Testing Summary Claim

{10}------------------------------------------------

Refine USA, LLC claims that the submitted VeinGogh instrument's EMC. Electrical Safety testing and Flammability testing data, further documents the submitter's claim of safety and substantial equivalence.

SUBSTANTIAL EQUIVALENCE SUMMARY - as required by 807.92.(b)(3)

The submitted instrument, Vein-Gogh, has the same indications for use as the predicate instrument: the Veinwave/TC3000 instrument manufactured by Newlands Clinical Trials, Ltd., Bolton, United Kingdom, and cleared under K083352.

For the most part, the VeinGogh instrument has the identical or very similar technological characteristics as the predicate device. The submitted instrument does not introduce any new indications for use and will perform in a substantially equivalent manner as the predicate device. Those few characteristics that the Submitted instrument has that are not found in the predicate device are typically the result of the interaction with potential users and their desire for functionality that improves their use of this technology.

However, while the submitter believes the characteristics are sufficiently precise to assure equivalence, the submitter has carried out validation, conformance to a number of International and National standard, and performance testing to further document substantial equivalence.

CONCLUSION - as required by 907,.92(b)(3)

This 510(k) submission documents that the VeinGogh instrument is substantially equivalent to the predicate Veinwave/TC3000 instrument.

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

MAY - 8 2012

Refine USA, LLC % Mr. Brian Smith President 340 3rd Avenue South, Suite C Jacksonville Beach, Florida 32250

Re: K112334 Trade/Device Name: VeinGogh™ instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: ONQ Dated: April 11, 2012 Received: April 23, 2012

Dear Mr. Smith:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{12}------------------------------------------------

Page 2 - Mr. Brian Smith

forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Sincerely yours,

Mark N. Millerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112334

VeinGogh™ instrument Device Name:

Indications for Use:

The VeinGogh device is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation..

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ or (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

Khumphrey Wagner
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112334

510(k) Number: K112334

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.