ScleroSafe 150 mm, ScleroSafe 350 mm
Device Facts
| Record ID | K231148 |
|---|---|
| Device Name | ScleroSafe 150 mm, ScleroSafe 350 mm |
| Applicant | Vvt Medical , Ltd. |
| Product Code | KRA · Cardiovascular |
| Decision Date | Jun 20, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1210 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (ScleroSafe) is intended for the delivery of Asclera®, an FDA-approved sclerosant (Asclera®), in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.
Device Story
ScleroSafe is a peripheral venous aspiration and infusion kit used by clinicians to treat superficial varicosities (2-3mm diameter). The device consists of a 5 Fr dual lumen catheter (DLC) and a Dual Procedure Syringe (DPS). The DLC is inserted over a 0.018-inch guidewire; once positioned, the guidewire is removed. The DPS, comprising two syringes in a plastic holder with plungers connected by a nylon wire, is attached to the catheter hub. Operation involves simultaneous injection of sclerosant through the outer lumen and aspiration of blood through the inner lumen, causing the vessel wall to collapse onto the catheter. The device is single-use, sterile (EtO), and disposable. It facilitates controlled delivery of sclerosant and vessel wall collapse, aiding in vein obliteration. Clinical benefits include effective vein treatment with minimal adverse events.
Clinical Evidence
Retrospective study of 20 patients (13 female, 7 male) with primary incompetent reticular leg veins (2-3 mm diameter). Primary endpoint: vein obliteration. Results: 100% complete obliteration achieved with no recurrence at 30 days. Safety: 3 minor events (small hematoma, phlebitis) reported, deemed not clinically significant. Animal study (ovine model) showed no adverse events and comparable tissue response to control.
Technological Characteristics
Dual lumen catheter (150mm/350mm), dual procedure syringe (piston-style), guidewire, needle, and torque tool. Materials: Polymer (injection molded). Sterilization: EtO. Biocompatibility: ISO 10993 compliant. Connectivity: None (manual operation). Mechanism: Reciprocal motion of dual syringe plungers via nylon wire for simultaneous injection/aspiration.
Indications for Use
Indicated for the delivery of Asclera® sclerosant in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.
Regulatory Classification
Identification
A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.
Predicate Devices
- ClariVein IC (K201907)
Reference Devices
- Procedur-10 Syringe Device (K042486)
Related Devices
- K250794 — InVera Infusion Device · Invera Medical · Mar 12, 2026
- K043019 — VASCULAR SOLUTIONS SCLERO-KIT · Vascular Solutions, Inc. · Dec 1, 2004
- K130671 — VENACURE EVLT NEVERTOUCH PROCEDURE KIT · AngioDynamics, Inc. · Mar 26, 2013
- K181044 — 400um Perforator and Accessory Vein Ablation Kit · AngioDynamics, Inc. · Jul 5, 2018
- K032805 — MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT · Vascular Solutions, Inc. · Oct 1, 2003
Submission Summary (Full Text)
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June 20, 2023
VVT Medical Ltd. % John Smith Partner Hogan Lovells US LLP 555 13th Street. NW Washington, District of Columbia 20004
Re: K231148
Trade/Device Name: ScleroSafe™ 150 mm, ScleroSafe™ 350 mm Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, FMF Dated: April 21, 2023 Received: April 21, 2023
Dear John Smith:
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 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements,
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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 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 (OS) 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH and 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 DICE (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe website 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,
Gregory W. Digitally signed by
Gregory W. O'connell -S
O'connell -S Date: 2023.06.20
13:12:49 -04'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K231148
Device Name ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
Indications for Use (Describe)
ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (ScleroSafe) is intended for the delivery of Asclera®, an FDA-approved sclerosant (Asclera®), in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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#### 510(k) SUMMARY
| Submitter: | John J. Smith<br>Hogan Lovells US LLP<br>john.smith@hoganlovells.com |
|----------------------------|---------------------------------------------------------------------------------|
| Phone: | 202.637.3638 |
| Sponsor: | Liron Tayeb<br>VVT Medical Ltd.<br>6 Hasadna St.<br>Kfar-Saba<br>4442405 Israel |
| Date Prepared: | June 15, 2023 |
| Name of Device: | ScleroSafe <sup>TM</sup> 150 mm, ScleroSafe <sup>TM</sup> 350 mm |
| Common or Usual Name: | Catheter/Syringe |
| Classification Name: | Continuous Flush Catheter/Piston Syringe |
| Regulatory Class: | Class II |
| Classification Regulation: | 21 CFR 870.1210, 21 CFR 880.5860 |
| Product Code: | KRA, FMF |
| Predicate Devices: | K201907, ClariVein IC, Merit Medical Systems, Inc. |
| Reference Devices: | K042486, Procedur-10 Syringe Device, Avanca Medical Devices, Inc |
#### Device Description
The subject device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (or ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe) is intended for the delivery of FDA-approved sclerosant Asclera® in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.
The ScleroSafe device includes a 5 Fr dual lumen catheter ("DLC"), mountable on a 0.018 inch straight-tipped guidewire in an over-the-wire configuration. The DLC is connected to a hub that splits the catheter into two separate tubes. One of the tubes ends with a blue luer lock for the aspiration extension and the other with a transparent luer lock for the injection. Following needle insertion into the guidewire is removed and a Dual Procedure Syringe ("DPS") is connected to the DLC hub via dedicated luers. The larger syringe (10 ml) is connected to blue luer lock connector (Aspiration Extension) of the smaller syringe (5 ml) is connected to a transparent luer lock connector of the catheter (Injection Extension) so fluids are simultaneously injected through one lumen and aspirated through another lumen. ScleroSafe is provided in two sizes: 150mm and 350mm.
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As explained in more detail below, ScleroSafe has the same general intended use and similar indications, technological characteristics, and principles of operation as the previously cleared predicate device, the ClariVein IC (K201907) and reference device Procedur-10 (K042486). A substantial equivalence chart comparing the similarities and differences between the ScleroSafe and its predicate device is provided in Table 1 below.
## Intended Use / Indications for Use
ScleroSafe Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe (ScleroSafe) is intended for the delivery of Asclera®, an FDA-approved sclerosant (Asclera®), in the treatment of varicosities in superficial veins with a diameter of 2 to 3mm.
## Summary of Technological Characteristics
The ScleroSafe is comprised of a dual lumen catheter, dual procedure syringe, guidewire, needle, and guidewire torque tool. The needle and the guidewire torque tool are off-the-shelf accessories. A comparison of the technical characteristics of the ScleroSafe dual lumen catheter, dual procedure syringe and guidewire to the predicate and reference devices are described below. In addition, substantial equivalence chart comparing the similarities and differences between the ScleroSafe and the predicate (ClariVein IC) and the reference device (Procedur-10) is provided in Table 1 below. Minor differences in the technological characteristics do not raise different questions of safety or effectiveness.
| | Subject Device<br>ScleroSafe | Predicate Device<br>ClariVein IC (Merit<br>Medical) | Reference Device<br>Procedur-10<br>(Avanca) | Comments |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ScleroSafe | ClariVein IC | Procedur-10 Syringe<br>Device | N/A |
| 510(k) Number | K231148 | K201907 | K042486 | N/A |
| Intended Use | ScleroSafe is<br>intended for the<br>delivery of Asclera®,<br>an FDA-approved<br>sclerosant (Asclera®),<br>in the treatment of<br>varicosities in<br>superficial veins with<br>a diameter of 2 to<br>3mm. | The ClariVein IC is<br>indicated for infusion<br>of physician-specified<br>agents in the<br>peripheral vasculature<br>(e.g. superficial veins,<br>saphenous veins). | Avanca's Procedur-10<br>device is used to<br>inject fluids into, or<br>withdraw fluids from,<br>the body | The subject and<br>predicate devices<br>are both intended<br>for the delivery of<br>agents into the<br>superficial /<br>saphenous veins.<br>In addition, the<br>subject and<br>reference device<br>are both indicated<br>for withdrawal of<br>fluids from the<br>body. |
| System | | | | |
| Components | The ScleroSafe is<br>comprised of a dual<br>lumen catheter, Dual<br>Procedure Syringe,<br>needle, guidewire and<br>guidewire torque tool | The ClariVein IC is<br>comprised of a<br>catheter assembly,<br>including the catheter<br>shaft, | The Procedur-10<br>device is a piston<br>syringe. | While there are<br>some differences<br>in components the<br>subject device was<br>extensively tested |
| | Subject Device<br>ScleroSafe | Predicate Device<br>ClariVein IC (Merit<br>Medical) | Reference Device<br>Procedur-10<br>(Avanca) | Comments |
| | | infusion port, and<br>rotatable wire, and is<br>connected by means<br>of a cartridge to an<br>integral self-contained<br>motor drive unit<br>(MDU). The MDU<br>includes the syringe<br>support, handle grip,<br>wire rotation speed<br>selectors, and trigger<br>features for<br>physician-controlled<br>infusion of a<br>physician-specified<br>agent.<br>The associated<br>accessories includes<br>a 5mL piston style,<br>luer syringe as a<br>convenience for the<br>user. | | and found to meet<br>internal<br>specifications,<br>relevant<br>international<br>standards and<br>FDA guidances<br>and no new<br>questions of safety<br>or effectiveness<br>were raised. |
| Technological<br>Characteristics<br>and<br>mechanism/<br>principle of<br>operation | Infusion catheter with<br>an inner and outer<br>lumen. When the<br>syringe is depressed<br>the sclerosant is<br>dispersed through<br>holes in the outer<br>lumen at the tip.<br>Simultaneously and<br>automatically blood is<br>withdrawn through the<br>inner lumen which<br>causes the vessel<br>wall to collapse on the<br>catheter. The<br>injection and<br>aspiration are<br>controlled by the<br>handle containing the<br>DPS which is<br>comprised of two<br>syringes that are<br>assembled in a plastic<br>holder. Syringe<br>plungers are<br>connected by a nylon<br>wire and operate with<br>a reciprocal motion. | Infusion catheter with<br>a rotating wire tip<br>designed for the<br>controlled 360-degree<br>dispersion of<br>physician-specified<br>agents to the targeted<br>treatment area. The<br>injection is controlled<br>by the handle<br>containing a syringe<br>and a motor. | Two syringes<br>assembled in a plastic<br>holder. Syringe<br>plungers are<br>connected by a pulley<br>and operate with<br>reciprocal motion.<br>Pressing one plunger<br>enables injection in<br>the syringe while<br>pressing the second<br>plunger enables<br>aspiration in the<br>syringe. Both injection<br>and aspiration are<br>possible, but not<br>simultaneously | While there are<br>minor differences<br>in the mechanism<br>of action, both the<br>subject and<br>predicate devices<br>are infusion<br>catheters that<br>utilize a syringe to<br>disperse a liquid<br>agent into the vein.<br>The subject and<br>reference device<br>both utilize two<br>syringes<br>assembled in a<br>plastic holder that<br>operate in a<br>reciprocal motion<br>to allow for<br>injection and<br>withdrawal of fluid. |
| | Subject Device<br>ScleroSafe | Predicate Device<br>ClariVein IC (Merit<br>Medical) | Reference Device<br>Procedur-10<br>(Avanca) | Comments |
| Sizes | 150mm and 350mm | 45cm, 65cm, 85cm | N/A | The subject and<br>predicate devices<br>are offered in<br>different sizes<br>however, the size<br>does not raise any<br>new questions of<br>safety or<br>effectiveness. |
| Compatibility | The device can be<br>used to treat veins<br>ranging in size from<br>2mm to 3mm in<br>diameter, and can<br>inject between 0-5ml<br>liquid. | The device can be<br>used with 4F<br>introducer sheath, to<br>treat veins from 2mm<br>in diameter, and can<br>inject between 0-5ml<br>liquid. | The device can inject<br>between 0-10ml<br>liquid. | The subject and<br>predicate devices<br>have the capacity<br>to inject the<br>identical quantity<br>of liquid (0-5ml).<br>Both can treat<br>veins in the range<br>of 2-3mm.<br>The capacity for<br>the subject device<br>falls within the<br>capacity of the<br>reference device. |
| Sterility | The ScleroSafe is<br>labeled sterile (EtO).<br>It has no serviceable<br>or reusable<br>parts. It is entirely<br>disposable post<br>procedure. | The ClariVein IC is<br>labeled sterile (EtO).<br>It has no serviceable<br>or reusable<br>parts. It is entirely<br>disposable post<br>procedure. | The Procedur-10 is<br>labeled sterile (EtO).<br>It has no serviceable<br>or reusable<br>parts. It is entirely<br>disposable post<br>procedure. | Same |
| Reuse durability | Single use | Single use | Single use | Same |
| Biocompatibility | Compliant with ISO<br>10993-1. | Compliant with ISO<br>10993-1. | Compliant with ISO<br>10993-1. | Same |
| Packaging | Tyvek pouch | Pouch | Blister pack | The subject device<br>was tested per the<br>requirements of<br>ISO 11607 and<br>the package<br>integrity was found<br>to be unharmed,<br>functional and<br>effective<br>therefore, no new<br>questions of safety<br>or effectiveness<br>are raised. |
| Syringe type | Piston syringe | Piston syringe | Piston syringe | Same |
| Length | 14 cm (DPS1005) | Not specified | 14 cm | The subject and<br>reference device<br>are the same. |
| Nozzle type | Male luer lock | Male luer lock | Male luer lock | Same |
| Volume | 5cc<br>10cc | 5 cc | 10 cc | Same.<br>The subject device<br>falls within the<br>scope of the<br>reference device |
| | Subject Device<br>ScleroSafe | Predicate Device<br>ClariVein IC (Merit<br>Medical) | Reference Device<br>Procedur-10<br>(Avanca) | Comments |
| | | | | The subject device<br>has two sizes of<br>syringes, one that<br>is identical to the<br>predicate (5cc)<br>and one that<br>identical to the<br>referenced device<br>(10cc) |
| Barrel marking<br>specs | Every 1 ml | Every 1 ml | 2 ml | The subject and<br>predicate device<br>are the same. The<br>differences<br>between subject<br>and reference<br>devices do not<br>affect volume<br>accuracy<br>therefore, different<br>questions of safety<br>or effectiveness<br>are not raised. |
| Syringe<br>Housing<br>Material | Polymer (injection<br>molding) | ABS | Polymer (injection<br>molding) | The subject<br>devices were<br>tested per the<br>requirements of<br>ISO 10993 and<br>found to be<br>biocompatible<br>therefore, different<br>questions of safety<br>or effectiveness<br>are not raised. |
| Guidewire | | | | |
| Sizes | Diameter - 0.018 inch<br>(0.46mm)<br>Length -<br>50cm (for ScleroSafe<br>150mm)<br>95 cm (for ScleroSafe<br>350mm) | Diameter - 0.46mm<br>Length - 80 to<br>150mm | N/A | The subject and<br>predicate<br>guidewires have<br>the same diameter<br>and are offered in<br>multiple lengths.<br>The difference in<br>lengths does not<br>raise any new<br>questions of safety<br>or effectiveness. |
Table 1. Comparison between the Subject, Predicate and Reference Devices
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## Substantial Equivalence Discussion
The ScleroSafe device is substantially equivalent to the predicate device, ClariVein IC (K201907), and reference device, Procedur-10 (K042486). Both devices have intended use and similar technological characteristics (i.e., principles of operation, design features, and performance characteristics) as the predicate and reference devices. In particular, the ScleroSafe and ClariVein IC are both infusion catheters that allow the delivery of fluids into superficial veins. In addition, both catheters have a mechanism to ensure that the agent is spread evenly along the wall of the vein. Both
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devices are intended for short or transient use, in a health care setting, and are operated by an experienced user.
The key technological differences between the ScleroSafe and reference devices include the following:
#### Differences in principles of operation:
- The main differences between ClariVein IC and ScleroSafe are that ClariVein IC delivers the . sclerosant through a rotating wire that touches the vessel wall, while ScleroSafe disperses the sclerosant through holes in the outer lumen and withdraws blood through the inner lumen, causing the vessel wall to collapse on the catheter.
- . The Procedur-10 has no catheter.
### Differences in handle/syringe:
- . The main differences between the ScleroSafe and ClariVein IC regarding the syringe are that (1) the ScleroSafe utilizes a second syringe for the simultaneous withdrawal of blood; and (2) the ClariVein IC utilizes a motor to control rotation whereas the ScleroSafe does not.
- . The main difference between the ScleroSafe and Procedur-10 devices is that the ScleroSafe can be also used to simultaneously aspirate and inject fluids while the Procedur-10 device performs aspiration and injection separately.
### Performance Data
#### Design Verification Testing
Design verification testing included testing to demonstrate the functionality and conformance to product requirements of the dual lumen catheter, guidewire and dual procedure syringe. The bench testing was conducted pursuant to FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling (FDA's 2019 Guidewire Guidance) as well as ISO 10555-1:2013/Amd 1:2017 and ISO 25539-1:2017. All testing demonstrated that the ScleroSafe device met its performance specifications and performed as intended.
### Shelf Life
The ScleroSafe is provided in individual sterile packs comprised of a high-density polyethylene (HDPE) tray packaged in a Tyvek® pouch (single sterile barrier). The Tyvek® pouch is placed along with an Instructions for Use, into an individual shelf carton. Multiple shelf cartons are placed in a corrugated shipping box used for storage and transport. Packaging, transportation and shelf-life (both accelerated and real shelf life) studies were conducted according to ISO 11607 and passed all acceptance criteria. All studies were performed on sterile finished product, in compliance with applicable standards. The results demonstrated that the device maintains sterility and functionality throughout its 3 year shelf life.
#### Biocompatibility
The ScleroSafe device was evaluated for:
- Complement activation and hemolysis per 10993-4 (Biological evaluation of medical devices a. Part 4: Selection of tests for interactions with blood);
- b. Cytotoxicity per ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity):
- c. Skin irritation and intracutaneous reactivity test per ISO 10993-10 (Biological evaluation of
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medical devices - Part 10: Tests for skin irritation and skin sensitization);
- d. Acute systemic toxicity and pyrogenicity per ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity); and
- e. Particulate testing per the requirements of USP <788>.
Biocompatibility testing did not raise any biocompatibility concerns. In addition, particulate testing confirmed that the particulate matter present in the device meets the requirements of USP <788>.
## Usability
A human factors engineering usability study was conducted to evaluate device performance of the ScleroSafe for its intended users, uses, and use environments. Both objective feedback and risk analysis confirm that device performance by the intended users of the ScleroSafe device is acceptable, including performance of critical tasks in the expected use environment.
### Animal Testing
A GLP animal study was conducted to evaluate the safety and performance characteristics of the ScleroSafe in an ovine model. The ScleroSafe device demonstrated no clinical adverse events, no extravascular impact, and comparable pathological tissue responses compared to the control device in the chronic sheep saphenous vein sclerotherapy model.
## Clinical Testing
The company retrospectively evaluated the subject device in 20 ScleroSafe procedures that were performed in 20 patients in Germany. Twenty subjects (13 female, 7 male) with primary incompetent reticular leg veins (veins 2 to 3 mm in diameter) were treated with the ScleroSafe kit between January and June 2019. Subjects were included if they met the intended use and were not impacted by the contraindications described in the device's labeling. All subjects were assessed for safety and for obliteration of the vein. Complete obliteration of the vein was achieved in 100% of the patients with no recurrence within 30 days after the treatment (assessed by duplex check at follow up session). Three minor events were reported post procedure (small hematoma and phlebitis); however, they were not considered complications since it was deemed not to be a clinically significant adverse event attributed to the treatment and did not require additional significant treatment.
### Conclusions
In conclusion, the ScleroSafe device has the same intended use and very similar technological characteristics to its predicate and reference devices. Any differences in the indications for use and technological characteristics between the subject and predicate device are minor and do not raise new questions of safety or effectiveness. Bench, animal, usability, and clinical testing further support this conclusion and demonstrate that the ScleroSafe is substantially equivalent to the predicate and reference devices for its intended use.
