(175 days)
No
The description focuses on the physical components and the mechanism of action (radiofrequency ablation) without mentioning any computational or algorithmic processes that would typically involve AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used to treat superficial vein reflux by coagulating blood vessels, which is a therapeutic intervention aimed at resolving a medical condition.
No
The device is intended for endovascular coagulation of blood vessels to treat superficial vein reflux, which is a therapeutic intervention, not a diagnostic one. While it uses ultrasound for guidance, the primary function described is to treat a condition by ablating tissue, not to identify or characterize a disease.
No
The device description explicitly states it is composed of two basic components: an energy console or generator (digiRF) and catheters (EVSRF), which are hardware components.
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 blood vessels in patients with superficial vein reflux." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a system that uses radiofrequency energy to heat and ablate veins within the body. This is an interventional treatment, not a diagnostic test performed on samples outside the body.
- Mechanism of Action: The mechanism involves delivering energy to the vein wall to cause occlusion and resorption. This is a physical intervention, not a process of analyzing biological samples for diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the Venclose™ Radiofrequency System is a therapeutic device used for treating superficial vein reflux through a minimally invasive procedure performed directly on the patient. It does not perform any diagnostic testing on samples outside the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Venclose RF System is composed of two basic components: an energy console or generator (digiRF) and catheters (EVSRF) designed specifically to be used with the generator. The Venclose RF System uses resistive radiofrequency ablation via energy delivery to heat the wall of an incompetent vein with temperature-controlled RF energy to cause irreversible luminal occlusion, followed by fibrosis and ultimately resorption of the vein. The blood then naturally reroutes to healthy veins.
The technique involves percutaneous access and insertion of the EVSRF Catheter into the great saphenous vein (GSV) or other superficial vein under ultrasound guidance, injection of local anesthesia, and thermal energy from a radiofrequency generator (digiRF) applied into the target vein. As the EVSRF Catheter is withdrawn stepwise down the treated length of the vein, thermal damage is inflicted upon the venous endothelium and through the vein wall, resulting in contraction and ultimately destruction of the vessel. The procedure can be performed in an outpatient setting, without the need for general anesthesia, allowing for a walkin/walk-out procedure with minimal postoperative recovery time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound guidance
Anatomical Site
blood vessels, superficial vein, great saphenous vein (GSV)
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)
Non-Clinical Testing: Device testing was conducted to evaluate conformance to product specifications and applicable standards. Bench testing included but not limited to the following tests: Catheter Simulation Test, Temperature Test, Pressure Test, Tensile Test, Fluid Test.
Pre-clinical testing: Animal testing was conducted in a model previously used for research in endovenous ablation for similar devices. The chosen model provided great saphenous and common jugular veins that are sized similarly to human veins. The purpose of the study was to demonstrate proper functionality of the Venclose System in a pre-clinical environment. Objectives included insertion of the catheter though a sheath into the vein, navigation to the intended treatment site, ability to reach a predetermined treatment temperature within a specified time frame and then to hold that temperature for the remainder of the treatment cycle, and capability of reducing the diameter of the vein by an amount similar to that done with the predicate device. All of the objectives were met resulting in a satisfactory study conclusion.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract image of three human profiles facing to the right, resembling a stylized bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Venclose, Inc. % Ms. Pamela Buckman Pamela M. Buckman, MSN 2800 Pleasant Hill Road, Suite 175 Pleasant Hill, California 94523
Re: K160754
Trade/Device Name: Venclose™ Radiofrequency System (digiRF Generator, EVSRF Catheter) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 8, 2016 Received: August 11, 2016
Dear Ms. Buckman:
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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth
1
in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Christopher J. Ronk-S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160754
Device Name Venclose Radiofrequency System
Indications for Use (Describe)
The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular of blood vessels 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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3
510(K) SUMMARY
K Number: K160754
General Information
| Date Prepared: | September 8, 2016 |
|---|---|
| Proprietary Name: | Venclose™ RF Generator and Catheter System |
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Name and Reference: | Electrosurgical cutting and coagulation device and accessories |
| 21 CFR §878.4400 | |
| Regulatory Class: | Class II |
| FDA Panel: | General and Plastic Surgery |
| Product Code: | GEI |
| Applicant: | Venclose™, Inc. |
| 2570 N. First St. | |
| 2nd Floor #221 | |
| Tel: 844 834 6292 | |
| Fax: 844 834 6293 | |
| Brady Esch, CEO | |
| besch@venclose.com | |
| Contact: | Pamela M. Buckman, MSN |
| 2800 Pleasant Hill Rd., Suite 175 | |
| Pleasant Hill, CA 94523 | |
| Tel: 925 980 7007 | |
| Fax: 925 705 7381 | |
| pmbuckman@gmail.com |
Indication for Use:
The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.
Predicate Device(s):
The Venclose™ Radiofrequency System is substantially equivalent to the following predicate devices.
| K040638 | VNUS RF Generator |
|---|---|
| K061373 | VNUS ClosureFast Catheter |
4
Device Description:
The Venclose RF System is composed of two basic components: an energy console or generator (digiRF) and catheters (EVSRF) designed specifically to be used with the generator. The Venclose RF System uses resistive radiofrequency ablation via energy delivery to heat the wall of an incompetent vein with temperature-controlled RF energy to cause irreversible luminal occlusion, followed by fibrosis and ultimately resorption of the vein. The blood then naturally reroutes to healthy veins.
The technique involves percutaneous access and insertion of the EVSRF Catheter into the great saphenous vein (GSV) or other superficial vein under ultrasound guidance, injection of local anesthesia, and thermal energy from a radiofrequency generator (digiRF) applied into the target vein. As the EVSRF Catheter is withdrawn stepwise down the treated length of the vein, thermal damage is inflicted upon the venous endothelium and through the vein wall, resulting in contraction and ultimately destruction of the vessel. The procedure can be performed in an outpatient setting, without the need for general anesthesia, allowing for a walkin/walk-out procedure with minimal postoperative recovery time.
Materials:
Materials for use in the console are consistent with industry practice for durable cases containing electronic elements. The console is supplied in a non-sterile condition and is not intended to be in contact with the surgical field or the patient. The catheters are made of industry-typical, biocompatible, nonpyroqenic materials and are provided packaged in a sterile condition. They are intended for use in a sterile surgical environment and will make contact with the patient. Biocompatibility data demonstrates that the catheters are in compliance with ISO 10993.
Comparative Summary of Technological Characteristics:
The materials, design, energy source, software integration, sterility methods (EVSRF Catheter component only), environment of use and clinical applications for the Venclose™ Radiofrequency System are comparable to those identified for the predicate devices.
5
| COMPARISON
ITEMS | VNUS RF
Generator
K040638 | VNUS Closurefast™
Catheter
K061373 | SUBJECT DEVICE
K160754 |
|-------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Instrument
Cable | Attached to
catheter, connects
to generator, eight
feet long | | Attached to catheter,
connects to
generator, eight feet
long |
| Energy/
Frequency | Bipolar 460.8 kHz,
max 90 Volts | | Bipolar 460 kHz, max
24 Volts |
| Software | Software
Controlled | | Software Controlled |
| Maximum
Output Power | 6 W/cm (40 W into
catheter 7 cm
heating element) | | 6 W/cm (60 W into
catheter when
heating 10 cm
heating element) |
| Temperature
functional limits | 10°C to 130°C | | 10°C to 130°C |
| Input Voltage | 100/240 VAC 50-60
Hz | | 100/240 VAC 50-60
Hz |
| Touch Screen | None | | Included 7in
touchscreen |
| Weight | 20 lbs max | | 10 lbs max |
| Dimensions | 38 cm x 38 cm x 19
cm (15 in x 15 in x
7.5 in) | | 23 cm x 25 cm x 17
cm
(9 in x 10 in x 7 in) |
| Mode of Action | Delivers heat to
resistive element
within the catheter
component | | Delivers heat to
resistive element
within the catheter
component |
| Foot Pedal | Not available | | Optional |
| Length of Use | | Single
Use/Disposable | Single
Use/Disposable |
| Catheters | | | |
| Diameters | | 7F (2.3mm) | 6F (2.0 mm) |
| Insertable
Lengths | | 60 cm or 100 cm | 60 cm or 100 cm |
| Heating
element
Lengths | | 7cm (predicate
K061373) or separate
catheter with 3cm
(reference K111887) | Single, adjustable, 10
cm (default) or 2.5
cm |
| Handle, Cable
& Connector | | Integral to Catheter | Integral to Catheter |
| Heating Set
Temperature
Range | | 95-120°C — User
Select, default at
120°C | 120°C, non-
adjustable |
6
Non-Clinical Testing:
Device testing was conducted to evaluate conformance to product specifications and applicable standards.
Bench testing included but not limited to the following tests: Catheter Simulation Test, Temperature Test, Pressure Test, Tensile Test, Fluid Test.
Applicable Standards and Guidances are as follows:
- . Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters, March 16, 1995.
- ISO 10555-1:2013 Sterile, Single-Use Intravascular Catheters, Part 1: . General Requirements
- EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes
- EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
- IEC 62304:2006 Medical device software. Software life cycle processes
- . IEC 62366:2008 Medical devices. Application of usability engineering to medical devices
- . IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General . requirements for safety - Collateral Standard: Usability
Pre-clinical testing:
Animal testing was conducted in a model previously used for research in endovenous ablation for similar devices. The chosen model provided great saphenous and common jugular veins that are sized similarly to human veins. The purpose of the study was to demonstrate proper functionality of the Venclose System in a pre-clinical environment. Objectives included insertion of the catheter though a sheath into the vein, navigation to the intended treatment site, ability to reach a predetermined treatment temperature within a specified time frame and then to hold that temperature for the remainder of the treatment cycle, and capability of reducing the diameter of the vein by an amount similar to that done with the predicate device. All of the objectives were met resulting in a satisfactory study conclusion.
Rationale for Substantial Equivalence
Conclusions drawn from the non-clinical bench and animal testing demonstrate that the Venclose System is as safe, as effective and performs at least as safely and as effectively as the legally marketed devices (K040638 and K061373) for the requested intended use as identified in this Summary.