The EVRF has 2 major parts: 1) the generator and 2) the needle. The generator creates the impulse. The impulse can be set at between in 0.1 second increments. The combination of these two settings means that highly accurate doses of energy can be delivered. The system utilizes a current of 4MHz .The power and impulse values are accurately maintained by a microprocessor and displayed on a LCD screen. The values can be digitally adjusted. The ultra-fine needle (Product Code KCW) has a diameter of 0.075 mm allowing for accurate operation and is protected by a specific isolating sheath. The vessel is thermocoagulated without damaging the epidermis and surrounding tissue. Needles are nickel. In case of a nickel allergy, gold needles are also available. The needles are disposable and can be used for a complete session. The combination of the generator and insulated needle allows for a very precise amount of energy to be delivered to exactly the right place.

AI/ML Overview

The provided document is a 510(k) summary for the EVRF System. It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance or effectiveness beyond establishing substantial equivalence to a predicate device.

The 510(k) submission process is primarily to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove clinical efficacy through a comprehensive clinical trial with specific performance metrics and acceptance criteria.

However, based on the provided text, here’s an extraction of relevant details and an explanation of why a full table of acceptance criteria and a study proving their fulfillment isn't present in this type of document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify "acceptance criteria" in the sense of predefined performance targets for clinical outcomes (e.g., success rates, complication rates, or specific measurements of improvement). Instead, it focuses on demonstrating substantial equivalence to the predicate device, the Veinwave TC3000. The comparison table highlights that the key technological characteristics are identical or highly similar, suggesting that if the predicate device performs acceptably, then the new device, being substantially equivalent, should also perform acceptably.

Feature	EVRF System (New Device)	Veinwave TC3000 (Predicate Device)	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Indications for Use	Intended for epilation and treatment of lower limb spider veins/telangiectasia by thermocoagulation.	Intended for epilation and treatment of lower limb spider veins/telangiectasia by thermocoagulation.	Identical indications for use to predicate device.	The EVRF System's indications for use are identical to the predicate device.
Mode of Action	Thermocoagulation of tissue by administration of high frequency energy.	Thermocoagulation of tissue by administration of high frequency energy.	Identical mode of action to predicate device.	The EVRF System operates via thermocoagulation using high-frequency energy, identical to the predicate.
Mode of Delivery	Disposable Epilation Needle	Disposable Epilation Needle	Identical mode of delivery to predicate device.	The EVRF System uses disposable epilation needles, identical to the predicate.
Disposable Epilation Needle	Identical - Ballet Technologies LTD	Identical - Ballet Technologies LTD	Sourced from the same manufacturer as the predicate's needles.	Needles are from Ballet Technologies LTD, identical to those used with the predicate device.
Modality	Monopolar	Monopolar	Identical modality to predicate device.	The EVRF System is monopolar, identical to the predicate.
Frequency (Monopolar)	4 MHz	4 MHz	Identical frequency to predicate device.	The EVRF System uses a 4 MHz frequency, identical to the predicate.
Power Output (Monopolar, 500 ohms)	25 watt	25 watt	Identical maximum power output to predicate device.	The EVRF System has a 25-watt power output, identical to the predicate.
Electrical Safety/EMC	Passed IEC 60601-1, IEC 60601-1-2 EMC, and 60601-2-2.	(Not specified for predicate, but assumed to meet standards for marketing)	Compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.	The EVRF System passed IEC 60601-1, IEC 60601-1-2 EMC, and 60601-2-2 electrical safety testing.
Output Power & Pulse Setting Comparison (Bench Testing)	Output power and pulse setting comparison presented to establish substantial equivalence.	(Presumably stable and consistent output as a marketed device)	Bench testing demonstrating comparable output power and pulse settings to predicate.	Comparison bench testing was performed, and output power setting and pulse setting were presented to establish substantial equivalence.

Important Note: The "Acceptance Criteria" and "Reported Device Performance" in the table above are largely implied by the substantial equivalence argument within a 510(k) summary. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, not necessarily meeting specific clinical efficacy metrics.

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

The document mentions "Comparison bench testing was performed" for the device. This testing focused on comparing output power and pulse settings between the EVRF System and the predicate device.

Sample Size for Test Set: Not explicitly stated for the bench testing. It would typically involve multiple measurements to confirm consistency and accuracy of the device's output.
Data Provenance: The bench testing was presumably conducted by F Care Systems NV or a contracted lab. The document does not specify country of origin for bench testing data beyond the sponsor's location (Belgium). This was retrospective testing performed on the device to support its 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: Not applicable. The 510(k) summary does not mention a clinical study that required expert-established ground truth for a test set. The comparison was primarily technical between the new device and a predicate.
Qualifications of Experts: Not applicable for this type of submission.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There was no clinical test set requiring expert adjudication.

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

MRMC Study: No, a MRMC comparative effectiveness study was not done or reported in this 510(k) submission. The submission relies on substantial equivalence regarding technological characteristics and indications for use.
Effect Size with AI vs. without AI Assistance: Not applicable, as this device is an electrosurgical device and not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

6. Standalone Performance Study (Algorithm Only):

Standalone Study: No, this is not an algorithm-only device. It is a physical electrosurgical system. The concept of "standalone performance" as typically applied to algorithms for diagnostics does not directly apply here. The "standalone" performance that was assessed was the device's ability to accurately control and deliver energy, which was evaluated via bench testing.

7. Type of Ground Truth Used:

For the bench testing, the "ground truth" was likely instrumentation standards and measurements of electrical output (power, frequency, pulse duration). The device's output measurements were compared to its specified settings and to the known characteristics of the predicate device. There was no "clinical" ground truth like pathology or outcomes data presented to support a standalone clinical efficacy claim. The ground truth for the overall submission is implicitly that the predicate device is safe and effective when used as labeled.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is an electrosurgical hardware system, not a machine learning algorithm that requires a "training set" of data.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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K13028/3

510(k) Summary

MAR 7 2013

SPONSOR Company Name: Company Address:

F Care Systems NV Kontichsesteenweg 54 2630 Aartselaar Belgium

Telephone: Fax:

011 32 3 4515139

Rudi Devers

011 32 3 45151245

Contact Person:

September 18, 2012

Summary Prepared

Device Name Trade Name: EVRF Common/Usual Name: Electrosurgical Coagulation Device Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories Product Code: ONQ Device Class: Class II Regulation Number: 21 CFR 878.4400

Predicate Device Company Newlands Clinical Trials LTD

Product Veinwave TC3000 510(k) # K083352

Device Description

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Indications for Use

The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

Summary of Technological Characteristics

The EVRF method of action is the delivery of a controlled dose of high frequency energy to the vein, which stops the flow of blood to the area of concern. Once the flow of blood is interrupted, the appearance of the spïder veins is greatly reduced or eliminated. The power generator controls through a micro-controller the delivery of stable energy to the needle and creates the impulse. The system utilizes a current of 4MHz. The impulse can be set between 0.1 seconds and 0.8 second in 0.1-second increments. The power can be set between 1 watt and 25 watt in 1-watt increment for more precision in the treatment.

The remote control has been replaced by a touch screen display allowing an easy access to the function of the EVRF.

The number of impulse per second can be set to 1 or 2 impulses per second The casing of the unit has been redesigned for marketing and ergonomic purposes only. None of these improvements in design and technology are raising any new issues of safety or effectiveness

The needles used with this device are not cleared as a part of this device system, as they are a Class I, 510(k) exempt device (FDA Product Code KWC).

Needles are purchased from Ballet Technologies, Ltd,

Establishment Registration # 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 EVRF device is substantially equivalent to the predicate device and does not raise new issues of safety and effectiveness.

Feature	F Care Systems NVEVRF System	Newlands Clinical trials LTDVeinwave TC3000
510(k) Number		K083352
Classification and ProductCode	878.4400Product Code ONQ	878.4400Product Code ONQ

12.2 Predicate Product Comparison Table

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Feature	F Care Systems NVEVRF System	Newlands Clinical trials LTDVeinwave TC3000
Indications for Use	The EVRF System isintended for the epilationand for the treatment oflower limb spider vein ortelangiectasia bythermocoagulation.	The Weinwave TC3000System is intended for theepilation and for thetreatment of lower limbspider vein or telangiectasiaby thermocoagulation.
OTC or Rx	Rx	Rx
Mode of Action	Thermocoagulation oftissue by administration ofhigh frequency energy	Thermocoagulation oftissue by administration ofhigh frequency energy
Mode of Delivery	Disposable Epilation Needle	Disposable Epilation Needle
Disposable Epilation Needle	Identical - BalletTechnologies LTD	Identical - BalletTechnologies LTD
Modality	Monopolar	Monopolar
Frequency(Monopolar)	4 MHz	4 MHz
Power Output - monopolarbalanced at 500 ohms	25 watt	25 watt

12.3 Differences

Feature	F Care Systems NVEVRF System	Newlands Clinical trials LTDVeinwave TC3000
Frequency(Monopolar)	4 MHz	4 MHz

Software

The level of concern was determined to be moderate. The software information provided in this 510(k) followed the requirements found in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Issued May 11, 2005.

Safety Testing

The EVRF has passed the requirements for IEC 60601-1 and IEC 60601-1-2 EMC and 60601-2-2 electrical safety testing.

Comparison bench testing was performed -

Comparison of output power setting and pulse setting was presented to establish . substantial equivalence.
) OF

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three curved lines representing snakes or streams.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Underwriters Laboratories, Incorporated % Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062

March 7, 2013

Re: K130283

Trade/Device Name: EVRF System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: ONQ Dated: February 06, 2013 Received: February 27, 2013

Dear Mr. Devine:

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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Page 2 - Mr. Ned Devine

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/ycm115809.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 yours,

Peter D
Rümm-S

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

Enclosure

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Indications for Use Form

Indications for Use

510(k) Number (if known): _K130283

Device Name: EVRF System

Indications for Use:

The EVRF System is intended for the 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Surgical Devices
Division Sign-Off
510(k) Number:	K130283

	Long HChen-A
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	Digitally signed by Long H. Chen-ADN: c=US, o=U.S. Government,ou=People,cn=Long H. Chen-A0.9.2342.19200300.100.1.1=130036Date: 2013.03.07 14:33:44 -05'00'
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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.