Vessel Closure Device (VCD177213P)

{0}  September 17, 2026 VCD Medical S.R.L. % David Worrell Regulatory Consultant RQM+ 5000 Centregreen Way Suite 100 Cary, North Carolina 27513 Re: K260677 Trade/Device Name: Vessel Closure Device (VCD177213P) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: March 2, 2026 Received: March 2, 2026 Dear David Worrell: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260677 - David Worrell Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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- {2} K260677 - David Worrell Page 3 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, **RACHEL E. NEUBRANDER -S** for Katherine Trivedi Assistant Director DHT2B: Division of Circulatory Support, Structural, and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K260677 Device Name Vessel Closure Device (VCD177213P) Indications for Use (Describe) The Vessel Closure Device (VCD) is indicated for use in open general surgery and percutaneous procedures on superficial and perforator venous vessels, when occlusion through clamping by clips is required. A single clip is intended for vessels within the range of 2.0 and ≤ 7.0 mm in diameter. 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} VCD MEDICAL Page 1 of 6 K260677 ### 510(K) SUMMARY Vessel Closure Device # **A. Applicant Name, Address, Telephone** | Applicant name | VCD Medical, S.r.l. | | --- | --- | | Applicant address | Via Pietro Marone 28, 25124 BS, Italy | | Applicant phone | +39 345 4808994 | # **B. Applicant Contact** Mr. Francesco Piccagli Head of Firm francesco.piccagli@vcd-medical.com # **C. Primary Correspondent/Consultant** David Worrell Regulatory Consultant RQM+ dworrell@rqmplus.com # **D. Date Prepared** E. 16 September 2026 # **F. Device Name** | Device trade name: | Vessel Closure Device (VCD) | | --- | --- | | Device common name: | Implantable clip | | Classification name: | An implantable clip is a clip-like device intended to connect internal tissue to aid in healing. It is not absorbable. | | Device class: | Class II | | Classification regulation: | 21 CFR 878.4300 | | Product Codes: | FZP | # **F. Predicate Device** Amsel Occluder Device K140932 (primary predicate) LigaClip 20/20 Multiple Clip Applier K864102 (secondary predicate) # **G. Device Description** The Vessel Closure Device (VCD) allows for selective closure of superficial and perforator venous vessels using a clip. The VCD consists of: {5} VCD MEDICAL Page 2 of 6 - A metallic cannula, containing the pre-loaded implantable clip (distal and proximal clip elements, suture, and lock element). The cannula includes echogenic features at the distal end to facilitate real time visualization of the device under ultrasound. - A plastic handle that allows the operator to release the individual elements in the correct sequence with the pull-back slider that brings the two clip elements together to occlude the target vessel and cuts the connecting suture at the end of the procedure. # H. Indications for Use The Vessel Closure Device (VCD) is indicated for use in open general surgery and percutaneous procedures on superficial and perforator venous vessels, when occlusion through clamping by clips is required. A single clip is intended for vessels within the range of 2.0 and ≤7.0 mm in diameter. # I. Indications for Use Comparison The subject device includes a modified indication for use to allow ultrasound-guided (USG) percutaneous placement of the implantable clip, in addition to open surgical placement of the implantable clip, in superficial and perforator veins. The change in method of procedural access does not change the general purpose of the device or the function of the device and, therefore, the modified indications for use of the subject device fall within the same intended use as the primary predicate device. # J. Comparison of Technological Characteristics The subject device is substantially equivalent to the predicate device with respect to same intended use, and similar indications for use, technology, materials of construction, and performance. Table 1 summarizes the comparison between the subject device and the predicate device. Table 1. Comparison of Subject Device and Predicate Device | Feature | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | | Vessel Closure Device | Amsel Occluder Device K140932 | Ligaclip 20/20 Multiple Clip Applier K864102 | | Device Classification Name | Clip, implantable clip | Clip, implantable clip | Clip, implantable clip | | Regulation Number | 878.4300 | 878.4300 | 878.4300 | | Intended Use | Vessel ligation or occlusion | Vessel ligation or occlusion | Vessel ligation or occlusion | | Indications for Use | The Vessel Closure Device (VCD) is indicated for use in open general surgery and percutaneous | The Amsel Occluder Device is intended for use in open general surgery procedures on tubular | The LIGACLIP MCA Multiple Clip Applier has application for use on vessels or other tubular | {6} VCD MEDICAL Page 3 of 6 K26#### | Feature | Subject device | Primary predicate device | Secondary predicate device | | --- | --- | --- | --- | | | Vessel Closure Device | Amsel Occluder Device K140932 | Ligaclip 20/20 Multiple Clip Applier K864102 | | | procedures on superficial and perforator venous vessels, when occlusion through clamping by clips is required. A single clip is intended for vessels within the range of 2.0 and ≤7.0 mm in diameter. | structures or vessels wherever a metal ligating clip is indicated and within the size range of 2.0 and 7.0 mm. | structures wherever a metal ligating clip is indicated. The tissue ligated should be consistent with the size of the clip. | | Clinical procedure | Open general surgery and percutaneous procedures under ultrasound guidance | Open general surgery | Open general surgery | | Pre-loaded / Loaded in OR | Pre-loaded | Pre-loaded | Pre-loaded | | Clip size | One size | One size | One size | | Secure to vessel mechanism | External compressive force on the vessel | External compressive force on the vessel | External compressive force on the vessel | | Vessel occlusion method | Penetrating through (transfixing) the vessel using a needle and then compressing and locking the two occlusion elements; external vessel compression. | Penetrating through (transfixing) the vessel using a needle and then compressing and locking the two occlusion elements; external vessel compression. | Positioned around the external vessel wall, then squeezed closed by clip applier to occlude the vessel; external vessel compression | | Clip material | PEEK (Polyetheretherketone) | Nitinol | Titanium | | Device profile | 17G | 18G | 11 inches in length | The different technological characteristics in clip materials do not raise different questions of safety and effectiveness. Polymer clips and metallic clips both are biocompatible, suitable for long-term vessel occlusion, and remain in the body unless they are removed surgically. Metallic clips may interfere with MRI and CT scans depending on specific metals. ### K. Summary of Non-Clinical Testing Bench testing was conducted to verify the performance to specifications of the subject device, including dimensional, tensile, closure force, closure reliability, clip strength, delivery and deployment, corrosion resistance. {7} VCD MEDICAL Page 4 of 6 K26#### Shelf-life testing was performed to evaluate the stability of the sterile, finished Vessel Closure Device under accelerated ageing conditions equivalent to 12 months of anticipated storage conditions. Shelf life testing was conducted using the following FDA-recognized standards: - Accelerated Aging: ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices - Environmental Conditioning: ASTM D4432 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing - Simulated Distribution ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems - Visual Inspection ASTM F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection - Sterile Barrier Integrity: ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) - Seal Strength Testing: ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials Test results demonstrate the product performs as intended and the package maintains integrity for a shelf life up to 12 months. The Vessel Closure Device is provided STERILE. The sterilization method is ethylene oxide (EO). A sterilization validation demonstrated a sterility assurance level (SAL) of 10-6 for the device and was performed according to the following FDA-recognized standards: - ISO 11135 Medical devices – Validation and routine control of ethylene oxide sterilization - ISO 10993-7 Biological evaluation of medical devices – ethylene oxide sterilization residuals. Sterile barrier systems were evaluated for performance and stability in accordance with ISO 11607-1: Requirements for materials, sterile barrier systems, and packaging systems. The Vessel Closure Device is provided non pyrogenic. A biological evaluation was conducted for all patient-contacting materials of the Vessel Closure Device in accordance with FDA's guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a Risk Management Process. The biological evaluation included the following tests: - ISO 10993-4 Selection of tests for interactions with blood - ISO 10993-5 Tests for in vitro cytotoxicity - ISO 10993-6 Tests for local effects after implantation - ISO 10993-10 Tests for skin sensitization - ISO 10993-11 Tests for systemic toxicity {8} VCD MEDICAL Page 5 of 6 K26#### - USP <151> Pyrogen test - ISO 10993-18 Chemical characterization of materials - ISO 10993-23 Tests for irritation - ASTM F756-17 Standard practice for assessment of hemolytic properties of materials - ASTM F2888-19 An in vitro measure for hemocompatibility assessment of cardiovascular materials. Extractions for all biological testing were performed in accordance with ISO 10993-12, Methods for the establishment of allowable limits for leachable substances. The toxicological risk assessment of the chemical characterization data obtained for the VCD Implant component was performed in accordance with ISO 10993-17, Methods for the establishment of allowable limits for leachable substances. Based on the data and information evaluated, and from testing results it can be concluded that the VCD device is biocompatible according to ISO 10993-1 and FDA Guidance on biocompatibility. A usability study was conducted using the following FDA guidance and FDA-recognized standard: - FDA Guidance for Industry and Staff, titled, Applying Human Factors and Usability Engineering to Medical Devices - IEC 62366-1:2015/A1:2020 titled, Medical Devices – Part 1: Application of usability engineering to medical devices. Usability study results demonstrated the risks associated with healthcare practitioners performing safety-critical tasks when operating the subject device are mitigated to a sufficient level and that no further user interface design or labeling modifications are necessary. A GLP animal study was conducted to demonstrate the safety and performance of the Vessel Closure Device. The study assessed the safety and performance endpoints during open surgical and percutaneous procedures. The GLP animal study demonstrated acceptable device performance during the implantation procedure, both using open surgical and percutaneous approach, and at the identified timepoint compared to the control device. All pathology was equal to less than mild/moderate severity. Histopathology assessments showed acceptable tissue responses to the subject device at the identified timepoint compared to the control device. Device usability was considered similar (open surgical) or slightly better (percutaneously) than the control device (predicate device). ### L. Conclusion Non-clinical performance testing results demonstrate the subject device meets established specifications and conforms with FDA-recognized standards for medical devices. The subject device performs as well as the predicate device for its intended use and supports a determination of substantial equivalence. Bench testing, usability testing, and animal testing demonstrate the subject device is as safe and as effective as the predicate device. Differences in technological {9} VCD MEDICAL Page 6 of 6 K26#### characteristics between the subject device and predicate device do not raise different questions of safety or effectiveness. Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate device.