(25 days)
The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
The Venclose™ digiRF Generator is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter to be used with the generator (time, temperature, etc.), which is connected via a triaxial catheter connector port. The Venclose™ digiRF Generator is intended to be used with Venclose™ RF Catheter(s) (either the Venclose™ EVSRF Catheter or the Venclose™ Maven Catheter) as a system. 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 scope of this 510(k) is only the Venclose™ digiRF Generator as the generator software has been modified. The Venclose™ Maven Catheter is not in the scope of this submission as the changes discussed within this submission are only applicable to the Venclose™ digiRF Generator as used with the Venclose™ EVSRF Catheter. There is no change to the Venclose™ EVSRF Catheter, as previously cleared via K160754.
Based on the provided 510(k) Clearance Letter, the device in question is the "Venclose digiRF Generator" and the modifications are related to its software when used with the "Venclose EVSRF Catheter." The clearance letter states that the scope of this 510(k) is only the Venclose digiRF Generator as the generator software has been modified, and there is no change to the Venclose EVSRF Catheter.
The document explicitly states that the device is an "Electrosurgical Cutting And Coagulation Device And Accessories" and the testing performed was "Software Verification and Validation." There is no mention of a study involving human subjects, interpretation of medical images by experts, or any kind of diagnostic performance evaluation typically seen with AI/ML-based diagnostic devices.
Therefore, many of the requested criteria regarding acceptance criteria for diagnostic performance, ground truth establishment, expert adjudication, MRMC studies, and training/test set details for AI/ML models are not applicable to this submission. This is a clearance for a software modification to an electrosurgical generator, not a medical imaging AI/ML diagnostic aid.
Here's the breakdown of what can be gathered from the provided text, addressing the points where information is available and indicating where it is not applicable or not provided.
Device: Venclose digiRF Generator (VCRFG1) with Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
Type of Modification: Software Modification to the Venclose digiRF Generator.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a software modification to an electrosurgical generator, the acceptance criteria are not related to diagnostic performance metrics like sensitivity, specificity, or AUC, but rather to software functionality, safety, and effectiveness. The document states that internal risk assessments procedures were used.
| Acceptance Criterion (Software) | Reported Device Performance (Summary) |
|---|---|
| Functional Performance (e.g., proper execution of treatment parameters, temperature control, time management, connectivity with catheter) | "The results demonstrate that the technological characteristics and performance criteria of the modified Venclose™ digiRF Generator is comparable to the predicate devices and that it performs as safely and as effectively as the legally marketed predicate devices." (Implied successful completion of software verification and validation, meeting defined specifications) |
| Safety (e.g., absence of new hazards, proper error handling, electrical safety, EMC compliance) | "The results demonstrate that...it performs as safely...as the legally marketed predicate devices." (Implied successful safety testing) |
| Effectiveness (e.g., maintaining intended use and performance characteristics) | "The results demonstrate that...it performs as...effectively as the legally marketed predicate devices." (Implied successful effectiveness testing, maintaining intended function for endovascular coagulation) |
| Software Verification & Validation (e.g., adherence to software requirements, robust and reliable operation) | "Software Verification and Validation" was performed. Results demonstrated comparability to predicate devices. |
Note: Specific numerical acceptance values are not detailed in this public 510(k) summary, as they are typically proprietary and part of detailed engineering and software validation reports submitted to the FDA.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of an AI/ML diagnostic performance test set. The "test set" here refers to the software verification and validation activities. The document does not specify exact "sample sizes" (e.g., number of test cases or iterations) for the software testing. Data provenance is also not applicable in the context of clinical data for AI/ML, as the testing relates to engineering and software validation.
- Software Verification and Validation: This typically involves rigorous testing against defined requirements, including unit testing, integration testing, system testing, and perhaps regression testing. The "sample size" would relate to the number of test cases executed, input parameters varied, and error conditions simulated. Specific numbers are not provided in this summary.
- Data Provenance: Not applicable as no clinical data for diagnostic performance was used in this clearance for a software modification to an electrosurgical device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the sense of expert annotation of medical data, is not established for an electrosurgical generator's software modification. The "ground truth" for this device's performance would be its adherence to engineering specifications and its ability to safely and effectively deliver RF energy for its intended purpose, as measured by calibrated equipment and functional tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for consensus building among human experts for ground truth label generation in diagnostic studies. This process is not part of software verification and validation for an electrosurgical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC study is relevant for evaluating the impact of an AI/ML diagnostic device on human reader performance. This 510(k) is for a software modification to an electrosurgical generator, not a diagnostic AI/ML device. Therefore, no MRMC study was performed or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. "Standalone performance" refers to the diagnostic accuracy of an AI/ML algorithm by itself. This device is an electrosurgical generator. Its performance is measured by its ability to generate and deliver RF energy according to specifications, not by its diagnostic capabilities. The software's "performance" was evaluated through verification and validation activities.
7. The Type of Ground Truth Used
Not applicable in the AI/ML diagnostic sense. For this device, the "ground truth" for software validation would be derived from:
- Design Specifications: The documented requirements and expected behavior of the software and the device.
- Predicate Device Performance: The existing performance characteristics of the previously cleared predicate devices, to which the modified device is being compared for substantial equivalence.
- Engineering Standards and Measurements: Data from calibrated test equipment, electrical measurements, temperature readings, and time controls.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The software was likely developed using traditional software engineering methodologies.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML training set, there is no ground truth to establish for such a set.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 19, 2025
Venclose, Inc.
Kulveen Dhatt
Senior Manager, Regulatory Affairs
2570 N. First Street
2nd floor #221
San Jose, California 95131
Re: K252316
Trade/Device Name: Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories
Regulatory Class: Class II
Product Code: GEI
Dated: July 24, 2025
Received: July 25, 2025
Dear Kulveen Dhatt:
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.
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K252316 - Kulveen Dhatt
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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" (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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K252316 - Kulveen Dhatt
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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,
JAMES H. JANG -S
Digitally signed by JAMES H. JANG -S
Date: 2025.08.19 23:28:40 -04'00'
James Jang, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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K252316
Page 1 of 1
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K252316
Please provide the device trade name(s).
Venclose digiRF Generator (VCRFG1);
Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)
Please provide your Indications for Use below.
The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Venclose, Inc.
510(k) Summary
21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based is as follows:
1. Submitter Information:
Applicant: Venclose, Inc.
2570 N. 1st Street, Floor 2, #221
San Jose, CA 95131
Phone: 602-830-5365
Contact: Kulveen Dhatt, Senior Regulatory Affairs Manager
Date: July 24, 2025
2. Subject Device:
Device Trade Name: Venclose™ digiRF Generator
Classification Name: Electrosurgical, Cutting & Coagulation & Accessories (Product Code GEI)
Review Panel: General & Plastic Surgery
Regulation Number: 21 CFR 878.4400
3. Predicate Devices:
Venclose™ Radiofrequency System (digiRF Generator, Venclose™ EVSRF Catheter)
K160754; cleared September 9, 2016
Venclose™ digiRF Generator, K250068, cleared February 4, 2025
4. Device Description:
The Venclose™ digiRF Generator is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter to be used with the generator (time, temperature, etc.), which is connected via a triaxial catheter connector port. The Venclose™ digiRF Generator is intended to be used with Venclose™ RF Catheter(s) (either the Venclose™ EVSRF Catheter or the Venclose™ Maven Catheter) as a system. 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.
K252316
Page 1 of 3
Page 6
Venclose, Inc.
The scope of this 510(k) is only the Venclose™ digiRF Generator as the generator software has been modified. The Venclose™ Maven Catheter is not in the scope of this submission as the changes discussed within this submission are only applicable to the Venclose™ digiRF Generator as used with the Venclose™ EVSRF Catheter. There is no change to the Venclose™ EVSRF Catheter, as previously cleared via K160754.
5. Indications for Use of Device:
The Venclose™ System (Venclose™ digiRF Generator with EVSRF Catheter) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
6. Technological Comparison to Predicate Devices:
The scope of this 510(k) is only the Venclose™ digiRF Generator as the generator software has been modified. There is no change to the Venclose™ EVSRF Catheter, as previously cleared via K160754.
The technological characteristics of the subject device are substantially equivalent to those of the predicate devices, in terms of following:
- Intended Use
- Indications for Use
- Performance Characteristics
- Target Population
- Fundamental Scientific Technology
- Operating Principle (Mode of Action)
- Packaging Configuration
The subject device and the predicate devices are different in the following manner:
- Software Modification
7. Performance Testing Summary:
To demonstrate substantial equivalence of the subject device to the predicate devices, the technological characteristics and performance criteria were evaluated. Using the FDA Guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessments procedures, the following non-clinical tests were performed:
K252316
Page 2 of 3
Page 7
Venclose, Inc.
- Software Verification and Validation
The results demonstrate that the technological characteristics and performance criteria of the modified Venclose™ digiRF Generator is comparable to the predicate devices and that it performs as safely and as effectively as the legally marketed predicate devices.
8. Conclusion:
The modified Venclose™ digiRF Generator is substantially equivalent to the legally marketed predicate devices, Venclose™ Radiofrequency System (digiRF Generator, Venclose™ EVSRF Catheter; K160754) and Venclose™ digiRF Generator; K250068).
K252316
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§ 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.