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 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.

AI/ML Overview

The provided text describes a medical device, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm, and its premarket notification to the FDA. The document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons, rather than providing specific acceptance criteria and a detailed study report for a novel AI/ML device.

Therefore, many of the requested elements for AI/ML device evaluation (like MRMC studies, expert adjudication for ground truth of an AI model, training set size, etc.) are not present in this document as it pertains to a different type of medical device (a physical catheter/syringe system).

However, I can extract information related to the device's performance based on the clinical study part mentioned, even though it's not strictly "acceptance criteria" in the AI/ML sense, but rather a performance outcome from a human-in-the-loop clinical use evaluation.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent.

Device: ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (Peripheral Venous Aspiration & Infusion Kit with Dual Procedure Syringe)

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" in a table format for the clinical performance. Instead, it describes subjective outcomes for safety and efficacy in a clinical study.

Acceptance Criteria (Inferred from study outcomes)	Reported Device Performance (Clinical Study)
No clinical adverse events (Safety)	"The ScleroSafe device demonstrated no clinical adverse events, no extravascular impact..."
Comparable pathological tissue responses to control (Safety)	"...and comparable pathological tissue responses compared to the control device in the chronic sheep saphenous vein sclerotherapy model." (Animal Study)
Obliteration of treated veins (Efficacy)	"Complete obliteration of the vein was achieved in 100% of the patients"
No recurrence within 30 days (Efficacy)	"...with no recurrence within 30 days after the treatment (assessed by duplex check at follow up session)."
Non-significant complications (Safety)	"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."

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

Sample Size: 20 patients
Data Provenance:
- Country of Origin: Germany
- Retrospective or Prospective: Retrospective (The company retrospectively evaluated the subject device in 20 ScleroSafe procedures that were performed in 20 patients in Germany between January and June 2019).

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 clinical study describes outcomes (vein obliteration, recurrence, adverse events) which would have been assessed by treating physicians and follow-up clinicians, but the specific number and qualifications of independent experts establishing a "ground truth" for a test set are not mentioned, as this is not an AI/ML study involving image interpretation.

4. Adjudication method for the test set:

This information is not provided. As it's a clinical follow-up rather than multi-reader image interpretation, formal adjudication methods like 2+1 or 3+1 are typically not described in this context for human clinical assessment.

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 was not performed. This device is not an AI/ML diagnostic or assistive tool, but a physical medical device.

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

No. This is not an AI/ML algorithm. The performance described is of the physical device used by clinicians.

7. The type of ground truth used:

The "ground truth" in this context refers to the clinical outcomes and assessments by healthcare professionals.
- Obliteration/Recurrence: Assessed by "duplex check at follow up session." This implies sonographic assessment.
- Safety: Clinical observation and assessment of adverse events by treating staff.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The clinical study described served as a performance evaluation.

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

Not applicable. (See point 8).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

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

Submitter:	John J. SmithHogan Lovells US LLPjohn.smith@hoganlovells.com
Phone:	202.637.3638
Sponsor:	Liron TayebVVT Medical Ltd.6 Hasadna St.Kfar-Saba4442405 Israel
Date Prepared:	June 15, 2023
Name of Device:	ScleroSafe TM 150 mm, ScleroSafe TM 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

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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

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 DeviceScleroSafe	Predicate DeviceClariVein IC (MeritMedical)	Reference DeviceProcedur-10(Avanca)	Comments
Device Name	ScleroSafe	ClariVein IC	Procedur-10 SyringeDevice	N/A
510(k) Number	K231148	K201907	K042486	N/A
Intended Use	ScleroSafe isintended for thedelivery of Asclera®,an FDA-approvedsclerosant (Asclera®),in the treatment ofvaricosities insuperficial veins witha diameter of 2 to3mm.	The ClariVein IC isindicated for infusionof physician-specifiedagents in theperipheral vasculature(e.g. superficial veins,saphenous veins).	Avanca's Procedur-10device is used toinject fluids into, orwithdraw fluids from,the body	The subject andpredicate devicesare both intendedfor the delivery ofagents into thesuperficial /saphenous veins.In addition, thesubject andreference deviceare both indicatedfor withdrawal offluids from thebody.
System
Components	The ScleroSafe iscomprised of a duallumen catheter, DualProcedure Syringe,needle, guidewire andguidewire torque tool	The ClariVein IC iscomprised of acatheter assembly,including the cathetershaft,	The Procedur-10device is a pistonsyringe.	While there aresome differencesin components thesubject device wasextensively tested
	Subject DeviceScleroSafe	Predicate DeviceClariVein IC (MeritMedical)	Reference DeviceProcedur-10(Avanca)	Comments
		infusion port, androtatable wire, and isconnected by meansof a cartridge to anintegral self-containedmotor drive unit(MDU). The MDUincludes the syringesupport, handle grip,wire rotation speedselectors, and triggerfeatures forphysician-controlledinfusion of aphysician-specifiedagent.The associatedaccessories includesa 5mL piston style,luer syringe as aconvenience for theuser.		and found to meetinternalspecifications,relevantinternationalstandards andFDA guidancesand no newquestions of safetyor effectivenesswere raised.
TechnologicalCharacteristicsandmechanism/principle ofoperation	Infusion catheter withan inner and outerlumen. When thesyringe is depressedthe sclerosant isdispersed throughholes in the outerlumen at the tip.Simultaneously andautomatically blood iswithdrawn through theinner lumen whichcauses the vesselwall to collapse on thecatheter. Theinjection andaspiration arecontrolled by thehandle containing theDPS which iscomprised of twosyringes that areassembled in a plasticholder. Syringeplungers areconnected by a nylonwire and operate witha reciprocal motion.	Infusion catheter witha rotating wire tipdesigned for thecontrolled 360-degreedispersion ofphysician-specifiedagents to the targetedtreatment area. Theinjection is controlledby the handlecontaining a syringeand a motor.	Two syringesassembled in a plasticholder. Syringeplungers areconnected by a pulleyand operate withreciprocal motion.Pressing one plungerenables injection inthe syringe whilepressing the secondplunger enablesaspiration in thesyringe. Both injectionand aspiration arepossible, but notsimultaneously	While there areminor differencesin the mechanismof action, both thesubject andpredicate devicesare infusioncatheters thatutilize a syringe todisperse a liquidagent into the vein.The subject andreference deviceboth utilize twosyringesassembled in aplastic holder thatoperate in areciprocal motionto allow forinjection andwithdrawal of fluid.
	Subject DeviceScleroSafe	Predicate DeviceClariVein IC (MeritMedical)	Reference DeviceProcedur-10(Avanca)	Comments
Sizes	150mm and 350mm	45cm, 65cm, 85cm	N/A	The subject andpredicate devicesare offered indifferent sizeshowever, the sizedoes not raise anynew questions ofsafety oreffectiveness.
Compatibility	The device can beused to treat veinsranging in size from2mm to 3mm indiameter, and caninject between 0-5mlliquid.	The device can beused with 4Fintroducer sheath, totreat veins from 2mmin diameter, and caninject between 0-5mlliquid.	The device can injectbetween 0-10mlliquid.	The subject andpredicate deviceshave the capacityto inject theidentical quantityof liquid (0-5ml).Both can treatveins in the rangeof 2-3mm.The capacity forthe subject devicefalls within thecapacity of thereference device.
Sterility	The ScleroSafe islabeled sterile (EtO).It has no serviceableor reusableparts. It is entirelydisposable postprocedure.	The ClariVein IC islabeled sterile (EtO).It has no serviceableor reusableparts. It is entirelydisposable postprocedure.	The Procedur-10 islabeled sterile (EtO).It has no serviceableor reusableparts. It is entirelydisposable postprocedure.	Same
Reuse durability	Single use	Single use	Single use	Same
Biocompatibility	Compliant with ISO10993-1.	Compliant with ISO10993-1.	Compliant with ISO10993-1.	Same
Packaging	Tyvek pouch	Pouch	Blister pack	The subject devicewas tested per therequirements ofISO 11607 andthe packageintegrity was foundto be unharmed,functional andeffectivetherefore, no newquestions of safetyor effectivenessare raised.
Syringe type	Piston syringe	Piston syringe	Piston syringe	Same
Length	14 cm (DPS1005)	Not specified	14 cm	The subject andreference deviceare the same.
Nozzle type	Male luer lock	Male luer lock	Male luer lock	Same
Volume	5cc10cc	5 cc	10 cc	Same.The subject devicefalls within thescope of thereference device
	Subject DeviceScleroSafe	Predicate DeviceClariVein IC (MeritMedical)	Reference DeviceProcedur-10(Avanca)	Comments
				The subject devicehas two sizes ofsyringes, one thatis identical to thepredicate (5cc)and one thatidentical to thereferenced device(10cc)
Barrel markingspecs	Every 1 ml	Every 1 ml	2 ml	The subject andpredicate deviceare the same. Thedifferencesbetween subjectand referencedevices do notaffect volumeaccuracytherefore, differentquestions of safetyor effectivenessare not raised.
SyringeHousingMaterial	Polymer (injectionmolding)	ABS	Polymer (injectionmolding)	The subjectdevices weretested per therequirements ofISO 10993 andfound to bebiocompatibletherefore, differentquestions of safetyor effectivenessare not raised.
Guidewire
Sizes	Diameter - 0.018 inch(0.46mm)Length -50cm (for ScleroSafe150mm)95 cm (for ScleroSafe350mm)	Diameter - 0.46mmLength - 80 to150mm	N/A	The subject andpredicateguidewires havethe same diameterand are offered inmultiple lengths.The difference inlengths does notraise any newquestions of safetyor 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.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
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.(b)
Classification. Class II (performance standards).