(53 days)
The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.
Venclose Maven System consists of two (2) main components:
-
- Maven Catheter with integrated cable connector and,
- digiRF Generator which delivers radiofrequency (RF) energy to the Maven catheter. 2)
The Maven catheter is a sterile single-use disposable medical device for endovenous radiofrequency ablation. The primary components of the catheter include the shaft, handle and integrated connector cable. The catheter shaft is 6 French (6F = 2.0 mm in diameter) in profile, with an insertable length of 40 cm and a 0.5 cm heating coil. The catheter is energized by the digiRF Generator which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter.
The Venclose Maven System (digiRF Generator and Maven Catheter) uses resistive radiofrequency ablation (via energy delivered to heat the wall of an incompetent vein) with temperature-controlled RF energy, and an already widely accepted procedure to cause irreversible luminal occlusion. This is followed by fibrosis and ultimately resorption of the vein.
The Venclose Maven System (digiRF Generator and Maven Catheter) supports an optional foot pedal.
The acceptance criteria and device performance are described below, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Safe and effective for treatment of incompetent perforator veins without significant adverse outcomes | Observed to be safe and effective for treatment of incompetent perforator veins. | Clinical Study |
| Occlusion rate at 30-day follow-up | 80% | Clinical Study |
| Reflux-free rate at 30-day follow-up | 93% | Clinical Study |
Note: The text does not explicitly state pre-defined acceptance thresholds for occlusion and reflux-free rates; it only reports the achieved performance.
Study Information
The information provided relates to a clinical study.
2. Sample size used for the test set and the data provenance:
- Sample Size: 27 subjects
- Data Provenance: Prospective, single-investigator study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a company based in San Jose, California, suggesting a U.S. study.
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 text. The study is described as a "single-investigator study," but it does not specify how ground truth (e.g., incompetence of perforator veins, occlusion, reflux status) was established or adjudicated, nor does it detail the qualifications of any experts involved in assessing these outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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:
- No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is for endovascular coagulation, not an imaging-based diagnostic AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a medical instrument (catheter and generator) for a surgical procedure, not an algorithm or AI system.
7. The type of ground truth used:
- The ground truth for effectiveness (occlusion rate, reflux-free rate) was established through clinical assessment during the 30-day follow-up, likely using imaging techniques (e.g., ultrasound) to determine vein patency and reflux. The basis for determining initial "incompetent perforator veins" would also be clinical and imaging findings. For safety, ground truth was based on the absence of "significant adverse outcomes."
8. The sample size for the training set:
- This question is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as above.
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August 3, 2021
Venclose, Inc. Ms. Mai-Ly Wilcox, BS, RAC Sr. Director, Regulatory and Clinical Affairs 2570 N. First Street, Second Floor, #221 San Jose, California 95131
Re: K211806
Trade/Device Name: Venclose Maven System (digiRF Generator and Maven Catheter) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 10, 2021 Received: June 11,2021
Dear Ms. Wilcox:
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. 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 located 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.
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
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encies. You must comply with all the Act's
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A ) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211806
Device Name
Venclose Maven System (digiRF Generator and Maven Catheter)
Indications for Use (Describe)
The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
SUBMITTER l.
Venclose, Inc. 2570 N. First Street 2nd Floor, #221 San Jose, CA 95131
Phone: 844-834-6292
Contact Person: Ms. Mai-Ly Wilcox, BS
Date Prepared: August 2, 2021
ll. DEVICE
| Device Name: | Venclose Maven System (digiRF Generator andMaven Catheter) |
|---|---|
| Common or Usual Name: | Electrosurgical Cutting and Coagulating Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device andaccessories (21 CFR § 878.4400) |
| Regulatory Class: | II |
| Product Code | GEI |
III. PREDICATE DEVICES
| Primary Predicate Device: | VNUS RFS and RFSFlex Catheters |
|---|---|
| Primary Predicate Device 510(k) No.: | K052003 |
| Primary Predicate Classification Name: | Electrosurgical cutting and coagulation device andaccessories (21 CFR § 878.4400) |
| Primary Predicate Regulatory Class: | II |
| Primary Predicate Product Code: | GEI |
| Secondary Predicate Device: | Venclose digiRF Generator & EVSRF Catheters |
| Secondary Predicate Device 510(k)No.: | K160754 |
| Secondary Predicate DeviceClassification Name: | Electrosurgical cutting and coagulation device andaccessories (21 CFR § 878.4400) |
| Secondary Predicate Regulatory Class: | II |
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Image /page/4/Picture/0 description: The image shows the logo for VENCLOSE. The logo consists of a stylized letter V formed by several parallel lines that transition in color from yellow to orange to pink to purple. Below the V is the word "VENCLOSE" in a simple, sans-serif font, with a trademark symbol to the right of the word.
DEVICE DESCRIPTION IV.
Venclose Maven System consists of two (2) main components:
-
- Maven Catheter with integrated cable connector and,
- digiRF Generator which delivers radiofrequency (RF) energy to the Maven catheter. 2)
The Maven catheter is a sterile single-use disposable medical device for endovenous radiofrequency ablation. The primary components of the catheter include the shaft, handle and integrated connector cable. The catheter shaft is 6 French (6F = 2.0 mm in diameter) in profile, with an insertable length of 40 cm and a 0.5 cm heating coil. The catheter is energized by the digiRF Generator which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter.
The Venclose Maven System (digiRF Generator and Maven Catheter) uses resistive radiofrequency ablation (via energy delivered to heat the wall of an incompetent vein) with temperature-controlled RF energy, and an already widely accepted procedure to cause irreversible luminal occlusion. This is followed by fibrosis and ultimately resorption of the vein.
The Venclose Maven System (digiRF Generator and Maven Catheter) supports an optional foot pedal.
V. INDICATIONS FOR USE:
The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The technology and design features of the subject device are equivalent to the primary predicate device. Specifically, the underlying principle for both devices is to utilize RF based thermal energy to denature collagen and shrink/occlude venous vasculature safely and effectively.
At a high level, the subject and the primary predicate devices are based on the following same technological characteristics:
- . Catheter Diameter
- . Insertable Length
- Heating Element Length ●
- Catheter Structure ●
- Handle, Cable & Connector
- Visualization ●
The following technological differences exist between the subject and the primary predicate devices:
- . Heating Set Temperature Range
- Heating Method
- Treatment Time ●
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Image /page/5/Picture/0 description: The image shows the logo for VENCLOSE. The logo consists of a stylized letter V made up of several parallel lines that transition in color from yellow to orange to pink to purple. Below the V is the word "VENCLOSE" in gray sans-serif font.
The subject device is only a slight modification to the secondary predicate device (predecessor), EVSRF system. The subject device uses the same device components as the EVSRF system. The only differences in technological characteristics between the subject and the secondary predicate devices are the following:
- . Insertable Lengths
- Heating Element Lengths .
- Heating Set Temperature Range
VII. PERFORMANCE DATA
The following performance data were provided in support of substantial equivalence determination.
Biocompatibility
The Venclose Maven Catheter is manufactured using identical materials and is processed by similar manufacturing methods as the predecessor device. EVSRF Catheter. Therefore, the biocompatibility data for the EVSRF Catheter was adopted for the Maven Catheter. The biocompatibility testing was conducted in accordance with FDA guidance document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" issued on June 16, 2016, and the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a risk management process" as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation ●
- Systemic Toxicity ●
- Hemocompatibility
- . Pyrogen Testing
The subject device is considered to be an external communicating device in circulating blood with limited contact duration (≤ 24 hours).
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted for the Venclose Maven System (digiRF Generator and Maven Catheter). The system complies with the following standards:
- . IEC 60601-1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-2-2:2017, Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-1-6:2013, Medical electrical equipment Part 1-6: General requirements for . safety - Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices
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Image /page/6/Picture/0 description: The image shows the logo for VENCLOSE. The logo consists of the word "VENCLOSE" in a sans-serif font, with a stylized "V" above it. The "V" is made up of several parallel lines that are colored in a gradient from yellow to orange to pink.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance document dated May 11, 2005: "Guidance for the Content of Premarket Submissions for Software Contained Medical Devices".
Non-Clinical
Device testing was conducted to evaluate conformance to product specifications. Bench testing included but are not limited to the following tests: Fluid Inaress Test, Battery Test, Ablation Cycle Test, Temperature Accuracy Test, Tensile Test.
Clinical
An IDE prospective, literature controlled, confirmatory, single-investigator, nonrandomized study of the Venclose Maven System (digiRF Generator and Maven Catheter) to treat incompetent perforator veins (IPVs) was performed. The primary objective of the study was to confirm that the Maven device can be used as intended and can treat incompetent perforator veins without significant adverse outcomes related to the use of the device. The study enrolled 27 subjects. Based on the data, the Venclose Maven System (digiRF Generator and Maven Catheter) is safe and effective for treatment of incompetent perforator veins. In addition, the occlusion rate achieved was 80% and the reflux free rate achieved was 93% at the 30-day follow-up.
CONCLUSION VIII.
The conclusions drawn from the non-clinical performance tests and the clinical study demonstrate that the Venclose Maven System is as safe, as effective and performs as well as the Predicate Devices.
§ 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.