The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coaqulation of blood vessels in patients with superficial vein reflux.

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.

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.

AI/ML Overview

This FDA 510(k) summary for the Venclose digiRF Generator (K250068) focuses on substantial equivalence based on software modifications to an existing device.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not provide a table of specific acceptance criteria with corresponding performance metrics for the software modifications. It generally states that "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."

The acceptance criteria implied are that the modified software continues to allow the device to perform its intended function (endovascular coagulation of blood vessels) safely and effectively, with no adverse effects introduced by the software changes.

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

The document mentions "Software Verification and Validation" as a performed non-clinical test. However, it does not specify the sample size used for this test set (e.g., number of test cases, number of simulated scenarios). It also does not detail the data provenance (e.g., retrospective or prospective tests, or country of origin of data if real-world data was used, which is unlikely for software verification of this type of device).

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 software verification and validation, ground truth might be defined by expected outputs for given inputs, established through engineering specifications and design documents rather than clinical expert consensus. Clinical experts would likely be involved in defining the original device's performance requirements, but not necessarily in the technical software verification changes.

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

The document does not specify any adjudication method. It's highly probable that for software verification and validation, the "ground truth" (expected behavior or output) is defined by the device's design specifications and tested against these specifications, rather than through a human adjudication process for subjective interpretation as would be common in image analysis AI.

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 MRMC comparative effectiveness study was done or mentioned. This type of study is typically performed for AI-powered diagnostic or assistive devices where human interpretation is involved. The Venclose digiRF Generator is an electrosurgical device; the software modification is presumably to its control and operational parameters, not its interpretation of patient data for a human.

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

The non-clinical test mentioned is "Software Verification and Validation." This type of testing is inherently a standalone (algorithm only) performance evaluation against predefined specifications. The document doesn't explicitly label it as such, but it's the nature of verifying software changes in a medical device.

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

The ground truth for "Software Verification and Validation" tests would typically be the design specifications and expected behavior of the software as defined by the engineering and quality teams. This is not clinical ground truth like pathology or outcomes data, but rather technical correctness and adherence to specified functional and non-functional requirements.

8. The sample size for the training set:

Not applicable and not provided. This device is not an AI/ML device that requires training data in the conventional sense. The "software modifications" refer to changes in the control software of the electrosurgical generator, not a learning algorithm.

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

Not applicable and not provided, as there is no training set for this type of device modification.

Summary

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February 4, 2025

Venclose. Inc. Kulveen Dhatt Senior Regulatory Affairs Manager 2570 N. First Street 2nd floor #221 San Jose, California 95131

Re: K250068

Trade/Device Name: Venclose digiRF Generator (VCRFG1) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: January 9, 2025 Received: January 10, 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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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 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.

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-device-advicecomprehensive-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-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-regulatory

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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,

Digitally signed by James H. James H. Jang -S Date: 2025.02.04 Jang -S 15:31:39 -05'00'

For 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K250068

Device Name

Venclose digiRF Generator (VCRFG1)

Indications for Use (Describe)

The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coaqulation of blood vessels in patients with superficial vein reflux.

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.

Type of Use (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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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, #221San Jose, CA 95131
Phone:	602-830-5365
Contact:	Kulveen Dhatt, Senior Regulatory Affairs Manager
Date:	January 9, 2025

2. Subject Device:

Device Trade Name:	Venclose™ TM 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™ Maven System (digiRF Generator and Maven Catheter) K211806, cleared August 3, 2021

4. Device Description:

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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. There is no change to the Venclose™ Catheter(s), Venclose™ EVSRF Catheter and Venclose™ Maven Catheter, as previously cleared via their respective 510(k), K160754 and K211806.

5. Indications for Use of Device:

The Venclose™ System (Venclose™ digiRF Generator with EVSRF Catheter) is intended for endovascular coaqulation of blood vessels in patients with superficial vein reflux.

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.

6. Technological Comparison to Predicate Devices:

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 Modifications .

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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:

. 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™ Maven System (digiRF Generator and Maven Catheter; K211806).

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.