VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump.
The generator generates, controls and monitors RF energy and delivers energy to the active electrode.
The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels.
The single footswitch works as an on/off switch and the double footswitch works to increase the power output.
A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the electrodes.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the usual sense of a diagnostic or AI device that relies on performance metrics like sensitivity, specificity, or accuracy.

Instead, the document is a 510(k) Premarket Notification for a medical device called the "VVR Generator System," which is an electrosurgical cutting and coagulation device. The purpose of this notification is to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.

The "study" described is a compilation of non-clinical data, animal studies, and referenced clinical studies to support this claim of substantial equivalence, not to meet specific performance acceptance criteria for a diagnostic output.

Therefore, many of the requested categories in your prompt will not be directly applicable, as they relate to the performance evaluation of a diagnostic or AI algorithm, which is not the nature of this submission.

However, I can extract information related to the closest concepts in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity) for an AI or diagnostic device output. Instead, the "acceptance" is demonstrated through substantial equivalence to predicate devices. The "reported device performance" is framed in terms of similar technical characteristics, thermal effects, and clinical outcomes compared to the predicate devices.

Acceptance Concept (as inferred from 510(k))	Reported Device Performance (VVR Generator System)
Similar Design Characteristics	VVR Generator System has similar design characteristics to Predicate Device (A) (K040638) and Predicate Device (B) (K111887).
Similar Technical Specifications	Similar to predicate devices in: Regulation Number, Regulation Name, Product Code, Indications for Use, Prescription/OTC, Generator type, Output frequency, Power output, Active Electrode type, Length of Use, Diameters, Insertable Lengths, Heating element lengths, Handle.
Equivalent Thermal Effects on Tissue	Comparative evaluation showed similar heat damage area sizes to predicate device on liver, kidney, and muscle tissue.
Power Output Varies with Impedance	Power output decreased as impedance increased, as intended in its design.
Equivalent Effectiveness (Animal Study)	Similar occlusion rates and degrees of vein wall damage without perivenous side effects compared to control devices.
Equivalent Safety (Animal Study)	No significant difference in mean vein injury/thickness. No perivenous side effects.
Effectiveness (Clinical Study)	Treatment success rate of 97.7% for varicose veins.
Safety (Clinical Study)	Complications included 20 cases of bruising, 3 cases of recanalization, and 1 case of neovascularization, indicating a level of safety.

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

Animal Study:
- Sample Size: 7 dogs
- Origin: Animal model (dog)
Clinical Study (referenced):
- Sample Size: 60 patients (41 males, 19 females)
- Origin: Not explicitly stated, but implies real-world data (RWD) from a clinical setting where the device was used. This was a referenced study, not one conducted directly for this 510(k) submission.

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

This information is not provided in the document. For the animal study, evaluation methods (macroscopic, microscopic, ultrasonographic) are mentioned, but not the number or qualifications of experts. For the clinical study, it's a referenced study reporting outcomes.

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

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This device is an electrosurgical system, not an AI or diagnostic imaging device. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not applicable and was not performed/reported.

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

This device is an electrosurgical device, not an algorithm or AI. Performance is assessed through its direct physical and physiological effects, not through an algorithm's standalone diagnostic capabilities. So, this question is not applicable.

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

Animal Study:
- Macroscopic: 2,3,5-triphenyltetrazolium chloride stain (TTC) evaluation for tissue viability/injury.
- Microscopic: Hematoxylin and eosin (H&E) stain for histological evaluation.
- Ultrasonographic: For assessment of blood flow and vein status.
Clinical Study:
- Outcomes Data: Reported "success rate" and "complications" which are clinical outcomes.

8. The sample size for the training set:

This device is an electrosurgical system, not an AI or machine learning model that requires a training set. So, this question is not applicable.

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

As this is not an AI/ML device, there is no "training set" or ground truth established for one. So, this question is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it. The full name reads "U.S. Food & Drug Administration".

October 25, 2023

Starmed Co., Ltd. % Minsu Kim SR Consultant Mdas #302, 35, Dongtansancheok-ro 1-gil Hwaseong-si, Gyeonggi-do 18488 Korea. South

Re: K222997

Trade/Device Name: VVR Generator system Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 22, 2023 Received: September 22, 2023

Dear Minsu Kim:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm___identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

{1}------------------------------------------------

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Image /page/1/Picture/7 description: The image shows the name "Mark Trumbore" in a simple, sans-serif font. The name is stacked vertically, with "Mark" on top and "Trumbore" below. The text is black against a white background, creating a clear contrast.

Digitally signed by Mark Trumbore -S Date: 2023.10.25 08:58:21 -04'00'

Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

{2}------------------------------------------------

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K22997

Device Name VVR Generator System

Indications for Use (Describe)

VVR Generator system is intended for endovascular coagulation of Saphenous Veins in patients with superficial vein reflux.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

K222997

1. SUBMITTER INFORMATION

Manufacturer:	STARMED CO., LTD.B-Dong, 4F&12F, 158, Haneulmaeul-Ro. Ilsandong-Gu, Goyang-SiGyeonggi, Republic of Korea
Contact Person:	Honggeun Lee/Q&R senior managerTel) +82-31-816-3546(209)Fax) +82-31-816-4546Email) lhg1186@STARmed4u.com
Date Prepared:	September 26, 2022

DEVICE INFORMATION 2.

. Trade Name: VVR Generator svstem
. Common Name: Electrosurgical System
. Requlation Number: 21 CFR 878.4400
. Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories
. Regulation Class: Class II
Product Code: GEI
. General & Plastic Surgery Review Panel:

PREDICATE DEVICE INFORMATION 3.

Predicate Device (A): K040638 (VNUS Radiofrequency Generator, Model RFG2) .
. Predicate Device (B): K111887 (ClosureFAST Radiofrequency Catheter)

4. DESCRIPTION OF THE DEVICE

VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump.

The generator generates, controls and monitors RF energy and delivers energy to the active electrode.

The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels.

The single footswitch works as an on/off switch and the double footswitch works to increase the power output.

A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the electrodes.

INDICATION FOR USE 5.

VVR Generator system is intended for endovascular coagulation of Saphenous Veins in patients with superficial vein reflux.

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

TECHNICLOGICAL CHARACTERISTICS 6.

	Comparison Item	Subject Device	Predicate Device (A)	Predicate Device (B)
	510(k) Number	K222997	K040638	K111887
	Proprietary Name	VVR Generator,VIVA Pump,VENISTAR	VNUSRadiofrequencyGenerator	ClosureFASTRadiofrequencyCatheter
	Model Number	VVR10,VP01,VP01-1,3-VENI0030N,7-VENI0070N,3-VENI003090N,7-VENI007090N	Model RFG2	-
	Manufacturer	STARMED CO., LTD.	VNUS MedicalTechnologies, Inc.	Covidien
	Regulatory Class	Class II	Class II	Class II
	Regulation Number	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
	Product Code	GEI	GEI	GEI
	Indication for Use	VVR Generatorsystem is intended forendovascularcoagulation ofSaphenous Veins inpatients withsuperficial vein reflux.	The VNUSRadiofrequencyGenerator is intendedfor use with VNUSradiofrequencydevices intended forvessel and tissuecoagulation.	The VNUSClosureFASTCatheter is intendedfor endovascularcoagulation of bloodvessels in patientswith superficial veinreflux
	Prescription or OTC	Prescription	Prescription	Prescription
	Generator	Monopolar orBipolar	Bipolar	Bipolar
	Temperaturesensors	N/A	10°C - 130°C	-
	Impedancemonitor	10-800 ohms	N/A	-
	Continuitymonitor	Impedance andOutput	Temperature andOutput	-
	Outputfrequency	480 kHz±10%	460.8 kHz,	-
	Power output	Max power output<40W@VenistarMode	6 W/cm (40 W intocatheter 7 cmheating element)	-
	Active Electrode	Monopolar orBipolar	Bipolar	Bipolar
	Length of Use	Single Use/Disposable	-	SingleUse/ Disposable
	Diameters	7Fr	-	7Fr
	InsertableLengths	65cm or 90cm	-	60 cm or 100 cm
	HeatingelementLengths	3cm or 7cm	-	3cm or 7cm
	Handle	Integral to Catheter	-	Integral to Catheter
	Cable& Connector
	Materials	STS 304		Unknown
Accessory	Foot switch	Yes	No
	CoolingPump	Yes	No

{6}------------------------------------------------

The predicate device and the VVR Generator System have similar design characteristics and technical specifications.

The difference between the two devices is that the Predicate device delivers RF power output to the catheter electrode, heats the electrode to a constant temperature of 120 to coagulate the blood vessel, while the Venistar mode of the VVR Generator system controls power output by monitoring the impedance of the vascular tissue during the application. Ex vivo testing, animal studies and clinical evidence (RWD) have demonstrated that the two devices have similar performance characteristics and similar performance effects.

7. SUMMARY OF NON-CLINICAL DATA

Non-clinical tests were conducted to verify that the subject device met all design specifications as was substantially equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Sterilization and Shelf life ○

The subject device is supplied sterile and has a shelf life of 3 years from the date of manufacture. A sterilization assurance level of 10-6 is guaranteed through the EO gas sterilization process, and it has been verified according to the following standards.

AAMI TIR28: 2016 ●
ISO 11135:2014
ISO 11138-1:2017
ISO 11138-2:2017
ISO 11737-1:2018
ISO 11737-2:2009
ISO 11607-1:2009
ISO 11607-2:2006
ISO 10993-7:2008

Biocompatibility O

The subject device has a limited contact characteristic of less than 24 hours within blood vessels and complies with the following standards.

ISO 10993-1:2018
ISO 10993-4:2017
ISO 10993-5:2009
ISO 10993-10:2010
ISO 10993-11:2017

Electromagnetic Compatibility and Electrical Safety O

The Subject device is an active device and complies with the following general and particular standards.

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
IEC 60601-1-2:2014
IEC 60601-1-6:2013
IEC 60601-2-2:2017
Performance Testing Bench

In order to verify the design characteristics of the subject device as specified in the comparison table, bench

{7}------------------------------------------------

testing was performed in accordance with the FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" and "Premarket Notification for Bipolar Electrosurgical Vessel Sealers for General Surgery", including the test items below.

Thermal Effects on Tissue
A comparative evaluation of the thermal effect area of the VVR Generator System and the predicate device was performed. The evaluation was performed on coagulation in typical modes for liver, kidney and muscle tissue using electrodes of the same size from both devices. As a result of the test, the devices had similar heat damage area sizes and there was no significant difference.
Power Output Versus Impedance
The output of the VVR generator system was tested to verify that the output characteristics varied with impedance. The test results verified that the power output decreased as the impedance increased, which is in the intended design output of the VVR Generator System.

10. SUMMARY OF ANIMAL AND CLINICAL DATA

O Animal Study

Animal testing was conducted to verify the effectiveness and safety of the subject device compared to a 510 (k) cleared device in a dog model.

Seven dogs underwent ablation using the control device (ClosureFAST and RFG2) and the subject device (VENISTAR and VVR Generator), Ltd.) in the femoral and cephalic veins. The ablated vein was evaluated macroscopically (2,3,5-triphenyltetrazolium chloride stain, TTC), microscopically (hematoxylin and eosin stain) and ultrasonographic ally. The veins of 1 dog were evaluated on the day of ablation, while the ablated veins of the remaining 6 dogs were evaluated 2 weeks later.

A total of 23 veins (control: 11 veins; subject: 12 veins) were ablated in 7 dogs. Non-TTC stained vein wall areas were identified in all ablated veins. No significant difference was observed in mean vein injury and mean vein wall thickness between the control and experimental devices. There was no blood flow in all veins ablated with the VS, whereas there was residual blood flow in 1 vein ablated with the control device.

The control and subject devices appear to provide similar occlusion rates and degrees of vein wall damage without perivenous side effects.

Clinical Study. O
To support the equivalence of the VVR Generator System, a clinical study that evaluated the safety and effectiveness of the subject device were referenced.

A total of 60 patients (41 males and 19 females) with varicose veins treated with the VVR Generator System were treated in this study, including 79 cases of the great saphenous vein and 10 cases of the small saphenous vein. The mean follow-up was 190±130 days and the success rate of treatment with the VVR generator system was 97.7%. Complications included 20 cases of bruising, 3 cases of recanalization and 1 case of neovascularization. The VVR Generator System was effective and safe for the treatment of varicose veins.

11. CONCLUSION

A comparison of the technical characteristics of the VVR Generator System and the Predicate Device shows that they are very similar in design characteristics and technical specifications. Non-clinical tests per FDA recognized international standards and the FDA guidance on Electrosurgical Devices for General Surgery, animal studies and clinical evidence (RWD) support that the target device conforms to the recognized standard and is substantially equivalent to the predicate device for the intended use.

Therefore, VVR Generator System have been demonstrated to be equivalent to predicate devices.

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.