(392 days)
Not Found
No
The description focuses on the RF energy generation and delivery mechanism, with no mention of AI or ML algorithms for control, analysis, or decision-making.
Yes
The device is used for endovascular coagulation of saphenous veins to treat superficial vein reflux, which is a therapeutic intervention.
No
The device is described as a system for endovascular coagulation of saphenous veins, which is a treatment (therapeutic) rather than a diagnostic process.
No
The device description clearly outlines hardware components including a generator, active electrode, foot switch, and cooling pump, which are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endovascular coagulation of Saphenous Veins in patients with superficial vein reflux." This describes a therapeutic procedure performed within the patient's body to treat a medical condition.
- Device Description: The device description details a system that generates and delivers RF energy to tissue inside the body to cause coagulation. This is an interventional device.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is used to directly treat a condition within the body.
N/A
Intended Use / Indications for Use
VVR Generator system is intended for endovascular coagulation of Saphenous Veins in patients with superficial vein reflux.
Product codes
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saphenous Veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Animal Study:
- Study type: Animal testing
- Sample size: Seven dogs
- Data source: Dog model
- Key results: 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 ultrasonographically. 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:
- Study type: Clinical study (referenced)
- Sample size: 60 patients (41 males and 19 females)
- Data source: Patients with varicose veins treated with the VVR Generator System.
- Key results: 79 cases of the great saphenous vein and 10 cases of the small saphenous vein were treated. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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)
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4
510(k) Summary
K222997
1. SUBMITTER INFORMATION
| Manufacturer: | STARMED CO., LTD.
B-Dong, 4F&12F, 158, Haneulmaeul-Ro. Ilsandong-Gu, Goyang-Si
Gyeonggi, Republic of Korea |
|-----------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Honggeun Lee/Q&R senior manager
Tel) +82-31-816-3546(209)
Fax) +82-31-816-4546
Email) 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 | VNUS | |||
| Radiofrequency | ||||
| Generator | ClosureFAST | |||
| Radiofrequency | ||||
| Catheter | ||||
| Model Number | VVR10, | |||
| VP01, | ||||
| VP01-1, | ||||
| 3-VENI0030N, | ||||
| 7-VENI0070N, | ||||
| 3-VENI003090N, | ||||
| 7-VENI007090N | Model RFG2 | - | ||
| Manufacturer | STARMED CO., LTD. | VNUS Medical | ||
| Technologies, 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 Generator | |||
| system is intended for | ||||
| endovascular | ||||
| coagulation of | ||||
| Saphenous Veins in | ||||
| patients with | ||||
| superficial vein reflux. | The VNUS | |||
| Radiofrequency | ||||
| Generator is intended | ||||
| for use with VNUS | ||||
| radiofrequency | ||||
| devices intended for | ||||
| vessel and tissue | ||||
| coagulation. | The VNUS | |||
| ClosureFAST | ||||
| Catheter is intended | ||||
| for endovascular | ||||
| coagulation of blood | ||||
| vessels in patients | ||||
| with superficial vein | ||||
| reflux | ||||
| Prescription or OTC | Prescription | Prescription | Prescription | |
| Generator | Monopolar or | |||
| Bipolar | Bipolar | Bipolar | ||
| Temperature | ||||
| sensors | N/A | 10°C - 130°C | - | |
| Impedance | ||||
| monitor | 10-800 ohms | N/A | - | |
| Continuity | ||||
| monitor | Impedance and | |||
| Output | Temperature and | |||
| Output | - | |||
| Output | ||||
| frequency | 480 kHz±10% | 460.8 kHz, | - | |
| Power output | Max power output |