(270 days)
Not Found
No
The description focuses on the device's electrical and mechanical components, firmware for basic control panel interaction, and thermocoagulation technology. There is no mention of AI, ML, image processing, or data analysis for decision-making or automated adjustments based on patient or vein characteristics. The "Auto-Pulse functionality" appears to be a pre-set timing feature, not an adaptive AI/ML algorithm.
Yes
The device is intended for the treatment of lower limb spider veins or telangiectasia by thermocoagulation, which is a medical treatment.
No
Explanation: The device is intended for the treatment of lower limb spider veins or telangiectasia by thermocoagulation. It is a therapeutic device, not a diagnostic one.
No
The device is a hardware device that uses thermocoagulation via a needle and high-frequency current to treat spider veins. While it contains firmware, this is a component of the hardware system, not a standalone software-only device.
Based on the provided text, the VeinGogh device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- VeinGogh Function: The VeinGogh device directly treats spider veins and telangiectasias on the lower limbs using thermocoagulation. It delivers electrical energy into the body to heat and collapse blood vessels.
- No Specimen Analysis: The description does not mention the device analyzing any biological specimens taken from the patient. Its function is therapeutic, not diagnostic.
Therefore, the VeinGogh device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VeinGogh device is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
Product codes (comma separated list FDA assigned to the subject device)
ONQ
Device Description
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 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 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 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 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%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limb
Indicated Patient Age Range
adults
Intended User / Care Setting
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.
medical offices/clinic environment
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)
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.
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.
The submitter claims and documents conformance to electrical safety testing and plastic flammability testing:
- IEC 60601-2-2, 4th Edition, 2006, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
- EN 60601-1-2:2007/IEC 60601-1-2:2007 (Medical Electrical Equipment - collateral standard: electromagnetic compatibility - requirements.
- EC 60601-2-2:2006 Medical Electrical Equipment Particular requirement for the safety of high frequency surgical equipment - (EMC testing only)
- EN 55011:2007/A2:2007/CISPR 11:2003, Group 2, Class B, 2 pages.
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.
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.
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
§ 878.4400 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.
0
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, FL |
| 32250 |
Brian Smith, President Contact:
August 8, 2011 Preparation Date:
1
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
2
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 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 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 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.
3
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 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
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
4
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 Testing | ||
| Results | None referenced in 510(k) | |
| Summary | Referenced in 510(k) | |
| Summary | ||
| Certified to IEC 60101-2- | ||
| 2 Edition 5.0 2009-02 | ||
| Medical Electrical | ||
| Equipment Part 2-2 | Makes no Claim | Yes |
| UL 94 Flammability | ||
| testing | Makes no Claim | Passed |
| Finished Device | ||
| Dimensions - Top | 38 x 53 x 17 cm | 41 x 33 x 15 cm |
| Finished Device | ||
| Dimensions - 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 Device | ||
| Construction | Bottom section is made of | |
| steel & the top section is | ||
| made from injection | ||
| molded plastic | Enclosure is made from | |
| fiberglass filled resin & | ||
| internally coated with | ||
| conductive metallic layer | ||
| for EMC protection | ||
| Power Supply | In-house designed - 100V | |
| Output | OTS Medical Rated | |
| Astrodyne MKK 40D-24 | ||
| (24V Output) | ||
| Discrete Power Supply for | ||
| Safety Isolation | Yes | Yes |
| Isolation Capacitor in | ||
| Series with Treatment | ||
| Connection | 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 Output | ||
| Voltage | 500 V Maximum | 205 V Maximum (+/-10%) |
| Output Waveform | ||
| Frequency | 4MHz | 4MHz |
| High Voltage Pulse | ||
| Generator | Yes | Yes |
| Type of Generating Circuit | Fly-back Type | Fly-back Type |
| Return Electrodes | No | No |
| Patient Isolation from | ||
| Mains | Internal Isolation | |
| Capacitors in Series with | ||
| the output signal connector | Internal Isolation | |
| Capacitors in Series with | ||
| the output signal | ||
| connector | ||
| Neutral Connection to | ||
| Mains | Yes | Yes |
| Chassis Connector | 4mm Banana-type | |
| receptacle | Identical | |
| Foot Switch | Yes | Yes |
| Device Console | Proprietary to Device | Proprietary to Device, but |
| similar | ||
| Embedded Controller | ||
| Board | Yes | Yes |
| Firmware | Proprietary to Device | Proprietary to Device |
| LCD Display/Type | Yes/Monochrome | Yes/Color |
| Start-up "splash" screen | Display's Device name, SW | |
| version | Display's Device Name, | |
| SW version | ||
| Display Device Logo | Displays VEINWAVE name | Display's VeinGogh |
| Name/Logo | ||
| Display of "power" of the | ||
| voltage wave (Vpp) as a | ||
| % of Maximum power or | ||
| voltage | Yes | Yes |
| User control of high | ||
| frequency pulse as a % of | ||
| maximum | Yes | Yes |
| PRODUCT COMPARISON TABLE | ||
| Characteristic/Function | Veinwave device | |
| (predicate) | VeinGogh Instrument | |
| pulse amplitude | ||
| User controls the pulse | ||
| amplitude and pulse | ||
| duration for | ||
| thermocoagulation | Yes | Yes |
| Dissipated Power at 100% | ||
| Output Power with 300ms | ||
| pulse & 1000 Ohm load | 1.35W | 1.35W |
| Dissipated Power at | ||
| Typical Treatment Power, | ||
| assuming 1000 Ohms | 0.66W | 0.66W |
| Range of Peak to Peak | ||
| Pulse Amplitude | 80Vpp to 502Vpp | 98Vpp to 205Vpp (+/- |
| 10%) | ||
| Output Voltage Increases | ||
| at Low Settings | Yes | No |
| No user control or | ||
| measurement of power as | ||
| found in "electrosurgical | ||
| devices" | Yes | Yes |
| Relative power settings | ||
| from 5% to 100% | Yes | Yes |
| Power setting has a pre- | ||
| set or default | Yes | Yes |
| Maximum power setting | ||
| identified | Yes | Yes |
| No claim made to linearity | ||
| of power setting | Yes | Yes |
| Testing documents non- | ||
| linearity of power settings | Yes | Yes |
| Testing of optimum or | ||
| default setting as Vpp +/- | ||
| 4% | 207 | 205 |
| Testing of lowest stated | ||
| or recommended as Vpp | ||
| +/- 4% | 144 | 143 |
| Number of settings based | ||
| on the range of power | ||
| settings from lowest listed | ||
| or recommended | 3 | 14 |
| Nearly identical treatment | ||
| output signals at 100ms | ||
| burst | Yes | Yes |
| Nearly identical treatment | ||
| output signals at 200ms | ||
| burst | Yes | Yes |
| Nearly identical treatment | ||
| output signals at 400ms | ||
| burst | Yes | Yes |
| Nearly identical | ||
| treatment output signals | ||
| at 800ms burst | Yes | Yes |
| PRODUCT COMPARISON TABLE | ||
| Characteristic/Function | Veinwave device | |
| (predicate) | VeinGogh Instrument | |
| Labeling of Relative | ||
| Output Settings & | ||
| Relative Voltages on | ||
| Device & User Manual | No | Yes |
| Display of pulse duration | ||
| in 0.1 second | Yes | Yes |
| Control of pulse duration | ||
| in 0.1 second increments | Yes | Yes |
| User reset to zero | ||
| seconds | Yes | Yes |
| Measured pulse shapes at | ||
| low Vpp are similar | Yes | Yes |
| Measured pulse shapes at | ||
| medium Vpp are similar | Yes | Yes |
| Measured pulse shapes at | ||
| high Vpp are similar | Yes | Yes |
| Pre-set or default pulse | ||
| duration in seconds | 0.2 | 0.2 |
| Range of pulse duration | ||
| settings | 0.1 second to 0.8 second | 0.1 second to 0.8 second |
| Display of # of pulses in | ||
| treatment session | Yes | Yes |
| Pulse activation causes a | ||
| acoustic "beep" or short | ||
| audio tone | Yes | Yes |
| Pulse duration displayed | Yes | Yes |
| Timer display of length of | ||
| time device has been in | ||
| "run" mode | Yes | Yes |
| Reset timer to zero time | Yes | Yes |
| Display how many pulses | ||
| the device has performed | Yes | Yes |
| Reset display of pulses to | ||
| zero | Yes | Yes |
| Set "Standby" mode - | ||
| display current status | Yes, "Off" is their standby | Yes |
| Set "Run" mode - display | ||
| the current status | Yes | Yes |
| Auto-Pulse Enable | No auto-pulse functionality | User activated software |
| which provides the user | ||
| with an output pulse with a | ||
| user defined adjustable | ||
| delay between pulses | ||
| Auto-Pulse Disable | No auto-pulse functionality | User inactivates software |
| functionality | ||
| 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
6
7
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:
-
- IEC 60601-2-2, 4th Edition, 2006, Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment.
-
- EN 60601-1-2:2007/IEC 60601-1-2:2007 (Medical Electrical Equipment - collateral standard: electromagnetic compatibility - requirements.
-
- EC 60601-2-2:2006 Medical Electrical Equipment Particular requirement for the safety of high frequency surgical equipment - (EMC testing only)
-
- 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
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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