(60 days)
No
The device description and performance studies focus on the mechanical and material properties of a catheter and syringe system for delivering a sclerosant. There is no mention of AI or ML in the text.
Yes
The device is described as "intended for the delivery of Asclera®, an FDA-approved sclerosant ... in the treatment of varicosities in superficial veins," which directly indicates a therapeutic purpose.
No
Explanation: The device description states that the ScleroSafe is "intended for the delivery of FDA-approved sclerosant Asclera® in the treatment of varicosities in superficial veins." This indicates a therapeutic function (treatment), not a diagnostic function (identifying a condition).
No
The device description clearly outlines physical components like a catheter, guidewire, hub, tubes, luer locks, and syringes. The performance studies also detail bench testing, shelf life, biocompatibility, usability, and animal testing, all of which are associated with hardware devices.
Based on the provided information, the ScleroSafe™ 150 mm, ScleroSafe™ 350 mm device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of a sclerosant (Asclera®) to treat varicosities in superficial veins. This is a therapeutic procedure performed in vivo (within the living body).
- Device Description: The device is a catheter and syringe system designed for aspiration and infusion directly into a vein. This is a medical device used for a treatment procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside of the body on samples taken from the body. The ScleroSafe device is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
ScleroSafe™ 150 mm, ScleroSafe™ 350 mm
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.
Product codes
KRA, FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superficial veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care setting, and are operated by an experienced user.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification Testing: Testing to demonstrate the functionality and conformance to product requirements of the dual lumen catheter, guidewire and dual procedure syringe. 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 Testing: Packaging, transportation and shelf-life (both accelerated and real shelf life) studies were conducted according to ISO 11607 and passed all acceptance criteria. The results demonstrated that the device maintains sterility and functionality throughout its 3 year shelf life.
Biocompatibility Testing: 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);
- Cytotoxicity per ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity);
- Skin irritation and intracutaneous reactivity test per ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization);
- Acute systemic toxicity and pyrogenicity per ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity); and
- Particulate testing per the requirements of USP .
Biocompatibility testing did not raise any biocompatibility concerns. Particulate testing confirmed that the particulate matter present in the device meets the requirements of USP .
Usability Study: 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: Retrospective evaluation of the subject device in 20 ScleroSafe procedures performed in 20 patients in Germany. 20 subjects (13 female, 7 male) with primary incompetent reticular leg veins (veins 2 to 3 mm in diameter) were treated between January and June 2019. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Testing: Complete obliteration of the vein was achieved in 100% of the patients with no recurrence within 30 days after the treatment.
Predicate Device(s)
K201907, ClariVein IC
Reference Device(s)
K042486, Procedur-10 Syringe Device
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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,
1
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
2
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) | |
|---|---|
| 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. Smith
Hogan Lovells US LLP
john.smith@hoganlovells.com |
|----------------------------|---------------------------------------------------------------------------------|
| Phone: | 202.637.3638 |
| Sponsor: | Liron Tayeb
VVT Medical Ltd.
6 Hasadna St.
Kfar-Saba
4442405 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
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
ScleroSafe | Predicate Device
ClariVein IC (Merit
Medical) | Reference Device
Procedur-10
(Avanca) | Comments |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ScleroSafe | ClariVein IC | Procedur-10 Syringe
Device | N/A |
| 510(k) Number | K231148 | K201907 | K042486 | N/A |
| Intended Use | 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. | The ClariVein IC is
indicated for infusion
of physician-specified
agents in the
peripheral vasculature
(e.g. superficial veins,
saphenous veins). | Avanca's Procedur-10
device is used to
inject fluids into, or
withdraw fluids from,
the body | The subject and
predicate devices
are both intended
for the delivery of
agents into the
superficial /
saphenous veins.
In addition, the
subject and
reference device
are both indicated
for withdrawal of
fluids from the
body. |
| System | | | | |
| Components | The ScleroSafe is
comprised of a dual
lumen catheter, Dual
Procedure Syringe,
needle, guidewire and
guidewire torque tool | The ClariVein IC is
comprised of a
catheter assembly,
including the catheter
shaft, | The Procedur-10
device is a piston
syringe. | While there are
some differences
in components the
subject device was
extensively tested |
| | Subject Device
ScleroSafe | Predicate Device
ClariVein IC (Merit
Medical) | Reference Device
Procedur-10
(Avanca) | Comments |
| | | infusion port, and
rotatable wire, and is
connected by means
of a cartridge to an
integral self-contained
motor drive unit
(MDU). The MDU
includes the syringe
support, handle grip,
wire rotation speed
selectors, and trigger
features for
physician-controlled
infusion of a
physician-specified
agent.
The associated
accessories includes
a 5mL piston style,
luer syringe as a
convenience for the
user. | | and found to meet
internal
specifications,
relevant
international
standards and
FDA guidances
and no new
questions of safety
or effectiveness
were raised. |
| Technological
Characteristics
and
mechanism/
principle of
operation | Infusion catheter with
an inner and outer
lumen. When the
syringe is depressed
the sclerosant is
dispersed through
holes in the outer
lumen at the tip.
Simultaneously and
automatically blood is
withdrawn through the
inner lumen which
causes the vessel
wall to collapse on the
catheter. The
injection and
aspiration are
controlled by the
handle containing the
DPS which is
comprised of two
syringes that are
assembled in a plastic
holder. Syringe
plungers are
connected by a nylon
wire and operate with
a reciprocal motion. | Infusion catheter with
a rotating wire tip
designed for the
controlled 360-degree
dispersion of
physician-specified
agents to the targeted
treatment area. The
injection is controlled
by the handle
containing a syringe
and a motor. | Two syringes
assembled in a plastic
holder. Syringe
plungers are
connected by a pulley
and operate with
reciprocal motion.
Pressing one plunger
enables injection in
the syringe while
pressing the second
plunger enables
aspiration in the
syringe. Both injection
and aspiration are
possible, but not
simultaneously | While there are
minor differences
in the mechanism
of action, both the
subject and
predicate devices
are infusion
catheters that
utilize a syringe to
disperse a liquid
agent into the vein.
The subject and
reference device
both utilize two
syringes
assembled in a
plastic holder that
operate in a
reciprocal motion
to allow for
injection and
withdrawal of fluid. |
| | Subject Device
ScleroSafe | Predicate Device
ClariVein IC (Merit
Medical) | Reference Device
Procedur-10
(Avanca) | Comments |
| Sizes | 150mm and 350mm | 45cm, 65cm, 85cm | N/A | The subject and
predicate devices
are offered in
different sizes
however, the size
does not raise any
new questions of
safety or
effectiveness. |
| Compatibility | The device can be
used to treat veins
ranging in size from
2mm to 3mm in
diameter, and can
inject between 0-5ml
liquid. | The device can be
used with 4F
introducer sheath, to
treat veins from 2mm
in diameter, and can
inject between 0-5ml
liquid. | The device can inject
between 0-10ml
liquid. | The subject and
predicate devices
have the capacity
to inject the
identical quantity
of liquid (0-5ml).
Both can treat
veins in the range
of 2-3mm.
The capacity for
the subject device
falls within the
capacity of the
reference device. |
| Sterility | The ScleroSafe is
labeled sterile (EtO).
It has no serviceable
or reusable
parts. It is entirely
disposable post
procedure. | The ClariVein IC is
labeled sterile (EtO).
It has no serviceable
or reusable
parts. It is entirely
disposable post
procedure. | The Procedur-10 is
labeled sterile (EtO).
It has no serviceable
or reusable
parts. It is entirely
disposable post
procedure. | Same |
| Reuse durability | Single use | Single use | Single use | Same |
| Biocompatibility | Compliant with ISO
10993-1. | Compliant with ISO
10993-1. | Compliant with ISO
10993-1. | Same |
| Packaging | Tyvek pouch | Pouch | Blister pack | The subject device
was tested per the
requirements of
ISO 11607 and
the package
integrity was found
to be unharmed,
functional and
effective
therefore, no new
questions of safety
or effectiveness
are raised. |
| Syringe type | Piston syringe | Piston syringe | Piston syringe | Same |
| Length | 14 cm (DPS1005) | Not specified | 14 cm | The subject and
reference device
are the same. |
| Nozzle type | Male luer lock | Male luer lock | Male luer lock | Same |
| Volume | 5cc
10cc | 5 cc | 10 cc | Same.
The subject device
falls within the
scope of the
reference device |
| | Subject Device
ScleroSafe | Predicate Device
ClariVein IC (Merit
Medical) | Reference Device
Procedur-10
(Avanca) | Comments |
| | | | | The subject device
has two sizes of
syringes, one that
is identical to the
predicate (5cc)
and one that
identical to the
referenced device
(10cc) |
| Barrel marking
specs | Every 1 ml | Every 1 ml | 2 ml | The subject and
predicate device
are the same. The
differences
between subject
and reference
devices do not
affect volume
accuracy
therefore, different
questions of safety
or effectiveness
are not raised. |
| Syringe
Housing
Material | Polymer (injection
molding) | ABS | Polymer (injection
molding) | The subject
devices were
tested per the
requirements of
ISO 10993 and
found to be
biocompatible
therefore, different
questions of safety
or effectiveness
are not raised. |
| Guidewire | | | | |
| Sizes | Diameter - 0.018 inch
(0.46mm)
Length -
50cm (for ScleroSafe
150mm)
95 cm (for ScleroSafe
350mm) | Diameter - 0.46mm
Length - 80 to
150mm | N/A | The subject and
predicate
guidewires have
the same diameter
and are offered in
multiple lengths.
The difference in
lengths does not
raise any new
questions of safety
or effectiveness. |
Table 1. Comparison between the Subject, Predicate and Reference Devices
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6
7
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
8
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
9
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 .
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 .
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.