(211 days)
The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
The Veinwave/TC3000 system consists of a power generator and a needle through which a controlled dose of radio frequency energy is delivered and is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
The provided text is a 510(k) summary for the Veinwave/TC3000 device. While it details the device's technical characteristics and its substantial equivalence to predicate devices, it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.
The document states: "The information discussed above demonstrates that the Veinwave/TC3000 device is substantially equivalent to the predicate devices." This implies that the demonstration of substantial equivalence serves as the primary basis for market clearance, rather than a specific performance study with predefined acceptance criteria. Clinical studies with detailed methodology and results are not typically required for 510(k) submissions when substantial equivalence can be demonstrated through other means (e.g., comparison of technical characteristics, safety and performance testing to established standards).
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or details on MRMC and standalone studies, as this information is not present in the provided 510(k) summary.
In summary, the document does not provide the requested information regarding acceptance criteria and studies demonstrating their fulfillment.
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Submitter: Newlands Clinical Trials, Ltd.
Veinwave/TC3000 Premarket Notification: Traditional 510(k)
510(k) Summary
JUN 1 2 2009
;
| Submitter Name:Submitter | Newlands Clinical Trials, Ltd.Newlands Medical Centre |
|---|---|
| Address: | 315 Chorley New RoadBolton, UNITED KINGDOM BL1 5BP |
| EstablishmentRegistration # | 3006786864 |
| Owner/Operator # | 10022858 |
| Phone Number: | 603 369 3550 |
| Fax Number: | 603 369 3562 |
| Contact Person: | William Greenrose |
| Date Prepared: | 31 October 2008 |
| Device TradeName: | Veinwave/TC3000 |
| Common Name | Electrosurgical Coagulation Device |
| ClassificationName, Number &Product Code: | Electrosurgical cutting and coagulation device andaccessories878.4400GEI |
| Predicate Devices: | Surgi-Max Electrosurgery Generator - K061174 - EllmanInternational Inc.Primaeva Medical System - K080145 - Primaeva Medical,Inc. |
| Device Descriptionand Statement ofIntended Use | Device Description: The Veinwave/TC3000 system consistsof a power generator and a needle through which acontrolled dose of radio frequency energy is delivered and isintended for epilation, and for the treatment of lower limbspider vein or telangiectasia by thermocoagulation. |
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Submitter: Veinwave/TC3000 Newlands Clinical Trials, Ltd. Premarket Notification: Traditional 510(k) Intended Use: The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation. Summary of The Veinwave/TC3000 method of action is the delivery of a Technological controlled dose of high frequency energy to the vein, which Characteristics stops the flow of blood to the area of concern. Once the flow of blood is interrupted, the appearance of the spider veins is greatly reduced or eliminated. The power generator controls the delivery of energy to the needle and creates the impulse. The system utilizes a current of 4MHz. The impulse can be set between 0.2 seconds and 1 second in 0.1 second increments. The power can be set between 30% and 60% in 5% increments. Needles are purchased from Ballet Technologies, Ltd, Establishment Reqistration # 3005114964, as sterile, single-use, disposable needles and are device listed by Ballet as accessories to Needle-Type. High Frequency Epilators, Classification Code KCW: Conclusion The information discussed above demonstrates that the Veinwave/TC3000 device is substantially equivalent to the predicate devices. o This summary includes only information that is also Declarations covered in the body of the 510(k). o This summary does not contain any puffery or unsubstantiated labeling claims. o This summary does not contain any raw data, i.e., contains only summary data. o This summary does not contain any trade secret or confidential commercial information. o This summary does not contain any patient identification information.
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| Summary of Technical Characteristics | ||
|---|---|---|
| -- | -- | -------------------------------------- |
| Feature | Veinwave/TC3000 | Surgi-Max Electrosurgery Generator | Primaeva Medical System |
|---|---|---|---|
| 510(k) Number | K083352 | K061174 | K080145 |
| Manufacturer | Newlands ClinicalTrials, Ltd. | Ellman InternationalInc. | Primaeva Medical, Inc. |
| Classification # &Product Code | 878.4400GEI | 878.4400GEI | 878.4400GEI |
| Intended Use | The Veinwave/TC3000system is intended forepilation, and for thetreatment of lower limbspider vein ortelangiectasia bythermocoagulation. | Various, including:Hemostasis andNonablativeCoagulation for controlof bleeding, epilation,and telangiectasia | The Primaeva MedicalSystem is intended foruse in Dermatologicand General Surgicalprocedures forelectrocoagulation andhemostasis. |
| OTC or Rx | Rx | Rx | Rx |
| Mode of Action | Thermocoagulation oftissue byadministration of highfrequency energy | Thermocoagulation oftissue byadministration of highfrequency energy | Thermocoagulation oftissue byadministration of highfrequency energy |
| Mode of Delivery | Disposable epilationneedle | Various, includingdisposable needles | Reusable ElectrodeInsertion Device anddisposable ElectrodeCartridge |
| Modality | Monopolar | Monopolar & bipolar | |
| Frequency(monopolar) | 4 MHz | 4 MHz | |
| Power Output -monopolarbalanced at 500ohms | ~ 30 watt* | ~ 60 watt* |
- Surgi-Max has a higher wattage output because it is intended for surgical applications on larger vessels in addition to small veins, while the Veinwave is only intended for the listed uses on small veins.
Section 5.0: 510(k) Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newlands Clinical Trials Limited % Oserve America, Incorporated Mr. William Greenrose President 220 River Road Claremont, New Hampshire 03743
JUN 1 2 2009
Re: K083352
Trade/Device Name: Veinwave/TC3000 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: ONQ Dated: April 29, 2009 Received: May 1, 2009
Dear Mr. Greenrose:
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.
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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Page 2-Mr. William Greenrose
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson 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): K083352
Veinwave/TC3000 Device Name:
Indications For Use:
The Veinwave/TC3000 system is intended for epilation, and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ix Reporter for nix
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083352
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§ 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.