(183 days)
QEW, KRA
No
The description focuses on mechanical and electrical components for thrombus extraction and infusion, with no mention of AI/ML algorithms for decision-making, image analysis, or control.
Yes.
The device is intended for "mechanical de-clotting" and "infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature" to treat deep vein thrombosis, which are therapeutic interventions.
No
This device is a therapeutic device designed for mechanical de-clotting and infusion of fluids to remove thrombus from the peripheral vasculature, not for diagnosing conditions.
No
The device description clearly outlines physical components such as a catheter, basket, rotational thrombus-extractor with a helical coil, metal tube, DC motor, and batteries, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ReVene Thrombectomy Catheter is a mechanical device used within the body (in the peripheral vasculature) to physically remove blood clots. It is a therapeutic device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is for "mechanical de-clotting and controlled and selective infusion of physician specified fluids... in the peripheral vasculature." This describes a treatment procedure, not a diagnostic test.
- Device Description: The description details a mechanical system with a basket, extractor, motor, and batteries, all designed for physical interaction within the blood vessels.
- Clinical Study: The clinical study evaluates the device's ability to remove thrombus and its safety during the procedure, which are performance metrics for a therapeutic device.
In summary, the ReVene Thrombectomy Catheter is a medical device used for a therapeutic procedure (thrombus removal) performed in vivo, not a diagnostic test performed in vitro on a sample.
N/A
Intended Use / Indications for Use
The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.
Product codes
QEW, KRA
Device Description
The ReVene Thrombectomy Catheter is a rotational venous thrombus extraction system for the treatment of vessels greater than 6mm diameter. The device is designed to be used in a medical catheter laboratory and allows for optional infusion of thrombolytic agents.
The device is compatible with a 10Fr introducer and includes a wire-braided cobalt chromium basket for thrombus disruption. A rotational thrombus-extractor, consisting of a helical coil housed inside a metal tube, is powered by an internal DC motor and batteries. The extractor runs the length of the catheter, and when activated, the coil rotates and is designed to macerate and transport thrombus from the basket to a collection container outside the body.
The main features of device are:
- . The thrombus disruption cage
- . The non-vessel contact thrombus extractor
- . The handle
The ReVene Thrombectomy Catheter is packaged as a single unit and is sterilized using ethylene oxide. The device is provided sterile, non-pyrogenic and is for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
The device is used under fluoroscopy
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical catheter laboratory / catheter lab
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)
Performance Testing:
Vetex Medical Ltd. developed a design verification and validation bench testing program to evaluate the performance and safety of the ReVene Thrombectomy Catheter and testing included:
- Packaging and labelling inspection
- Pouch peel testing
- Bubble leak testing
- Radial force testing
- Conformity assessment
- . Catheter integrity testing:
- o Tensile testing
- o Compression testing
- O Torque resistance
- Kink resistance o
- . & Device visual dimensional inspection
- . Simulated Use testing
- . Post-use inspection
- . Corrosion testing
- Radiopacity testing
- Battery life testing
All tests met the pre-determined acceptance criteria. Aged testing has been performed to support a shelflife of 12 months for the ReVene Thrombectomy Catheter.
Biocompatibility Evaluation:
A biological evaluation was performed to evaluate the biological risks associated with the ReVene Thrombectomy Catheter per FDA's Guidance Use of International Standard ISO10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Testing was performed in accordance with Good Laboratory Practices (GLP; 21 CFR Part 58) and results demonstrate the ReVene Thrombectomy Catheter is biocompatible for its intended use.
Pre-Clinical Ovine Study:
The safety and performance of the ReVene Thrombectomy Catheter was successfully evaluated in an ovine model. The results demonstrate that the ReVene Thrombectomy Catheter will perform as intended.
Clinical Trial:
The Venous Thrombus Extraction (VETEX) Clinical Study is an open label, prospective, non-randomized, multi-centre evaluation of the ReVene Thrombectomy Catheter for the treatment of acute iliofemoral deep vein thrombosis (DVT). A total of 19 subjects were enrolled and treated with the ReVene Thrombectomy Catheter. The Primary Performance Endpoint was met in 19/19 (100%) of subjects, with all subjects achieving a Society of Interventional Radiology (SIR) Grade II Lysis (50-95% thrombus removal) or greater in the target vessel, with freedom from procedural related adverse events. There were no device-related adverse events in any subject. The ReVene Thrombectomy Catheter performed as intended in all cases when used per the instructions for use. Note: Although this study evaluated the ReVene Thrombectomy Catheter in patients with DVT, the device is not indicated for treatment of DVT in the US.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary Performance Endpoint was met in 19/19 (100%) of subjects, with all subjects achieving a Society of Interventional Radiology (SIR) Grade II Lysis (50-95% thrombus removal) or greater in the target vessel, with freedom from procedural related adverse events.
Predicate Device(s)
The Cleaner Rotational Thrombectomy System (K141617)
Reference Device(s)
No reference devices were used in this submission
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
December 22, 2020
Vetex Medical, Ltd. Mark Bruzzi CEO Business Innovation Center, NUI Galway Newcastle Road Galway, Ireland
Re: K201705
Trade/Device Name: ReVene Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: November 23, 2020 Received: November 24, 2020
Dear Mark Bruzzi:
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 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.
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
1
801); medical device 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 (QS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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 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) K201705
Device Name ReVene Thrombectomy Catheter
Indications for Use (Describe)
The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter: | Vetex Medical Ltd., |
|---|---|
| Business Innovation Centre, | |
| NUI, Galway, Newcastle Road, | |
| Galway, Ireland | |
| Contact person: | Mark Bruzzi |
| CEO | |
| Tel: +353 91 394795 | |
| Date Summary was prepared: | 18 Dec 2020 |
| Trade Name: | ReVene Thrombectomy Catheter |
| 510(k) Number | K201705 |
| Common/Usual Name: | Thrombectomy catheter |
| Classification Name: | Continuous Flush Catheter, (21 CFR 870.1210, product code KRA) |
| Embolectomy Catheter, (21 CFR 870.5150, product code QEW) | |
| Predicate device: | The Cleaner Rotational Thrombectomy System (K141617). |
| This predicate device has not been subject to a design-related | |
| recall. | |
| Reference devices: | No reference devices were used in this submission |
Device Description
The ReVene Thrombectomy Catheter is a rotational venous thrombus extraction system for the treatment of vessels greater than 6mm diameter. The device is designed to be used in a medical catheter laboratory and allows for optional infusion of thrombolytic agents.
The device is compatible with a 10Fr introducer and includes a wire-braided cobalt chromium basket for thrombus disruption. A rotational thrombus-extractor, consisting of a helical coil housed inside a metal tube, is powered by an internal DC motor and batteries. The extractor runs the length of the catheter, and when activated, the coil rotates and is designed to macerate and transport thrombus from the basket to a collection container outside the body.
The main features of device are:
- . The thrombus disruption cage
- . The non-vessel contact thrombus extractor
- . The handle
4
The ReVene Thrombectomy Catheter is packaged as a single unit and is sterilized using ethylene oxide. The device is provided sterile, non-pyrogenic and is for single-use only.
Indications for Use
The ReVene Thrombectomy Catheter is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics in the peripheral vasculature. The Indications for Use statement is identical to the predicate device.
Comparison of Technological Characteristics with the Predicate Device
The ReVene Thrombectomy Catheter is substantially equivalent to the Cleaner Rotational Thrombectomy System (K141617) in its intended use, principles of operation, design, materials, and sterile package configuration. The design differences have been evaluated through pre-clinical in vitro and in vivo testing.
| Attribute | ReVene Thrombectomy Catheter | Cleaner Rotational Thrombectomy System (Cleaner XT and Cleaner 15)
(K141617) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The device is intended for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature. | Same |
| Indications for use | The device is intended for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics in the peripheral vasculature. | Substantially equivalent.
Mechanical de-clotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
Mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature. |
| Device Class | Class II | Same |
| Product Code | KRA
QEW | KRA |
| Prescription Device | Yes | Same |
| Catheter Type | Mechanical Thrombectomy Catheter | Same |
Table 1: Substantial Equivalence Comparison: ReVene versus Predicate Device
5
| Attribute | ReVene Thrombectomy Catheter | Cleaner Rotational Thrombectomy
System (Cleaner XT and Cleaner 15)
(K141617) |
|---------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------|
| Indicated Vessel Diameter | >6mm | Same |
| Sterilization Method | EtO | Same |
| Working Length | 90cm | Substantially equivalent: 65cm, 135cm |
| Rotating wire | Yes | Same |
| Power source | Battery | Same |
| Voltage | 9V | Same |
| Power activation | Switch located on handle | Same |
| Conditions of use | The device is used under fluoroscopy
in a catheter lab | Same |
| Principle of operation | Mechanical clot disruption combined
with extraction | Same |
| Access method | Access via introducer sheath | Same |
| Sheath compatibility | 10F | Substantially equivalent: 7F |
| Radiopacity | Radiopaque marker band on distal end | Substantially equivalent. Radiopaque distal tip and sinusoidal wire. |
| Energy source Location | Battery & motor in device handle | Same |
6
Performance Testing
Vetex Medical Ltd. developed a design verification and validation bench testing program to evaluate the performance and safety of the ReVene Thrombectomy Catheter and testing included:
- Packaging and labelling inspection
- Pouch peel testing
- Bubble leak testing
- Radial force testing
- Conformity assessment
- . Catheter integrity testing:
- o Tensile testing
- o Compression testing
- O Torque resistance
- Kink resistance o
- . & Device visual dimensional inspection
- . Simulated Use testing
- . Post-use inspection
- . Corrosion testing
- Radiopacity testing
- Battery life testing
All tests met the pre-determined acceptance criteria. Aged testing has been performed to support a shelflife of 12 months for the ReVene Thrombectomy Catheter.
Biocompatibility Evaluation
A biological evaluation was performed to evaluate the biological risks associated with the ReVene Thrombectomy Catheter per FDA's Guidance Use of International Standard ISO10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Testing was performed in accordance with Good Laboratory Practices (GLP; 21 CFR Part 58) and results demonstrate the ReVene Thrombectomy Catheter is biocompatible for its intended use.
Pre-Clinical Ovine Study
The safety and performance of the ReVene Thrombectomy Catheter was successfully evaluated in an ovine model. The results demonstrate that the ReVene Thrombectomy Catheter will perform as intended.
Clinical Trial
The Venous Thrombus Extraction (VETEX) Clinical Study is an open label, prospective, non-randomized, multi-centre evaluation of the ReVene Thrombectomy Catheter for the treatment of acute iliofemoral deep vein thrombosis (DVT). A total of 19 subjects were enrolled and treated with the ReVene Thrombectomy Catheter. The Primary Performance Endpoint was met in 19/19 (100%) of subjects, with all subjects achieving a Society of Interventional Radiology (SIR) Grade II Lysis (50-95% thrombus removal) or greater in the target vessel, with freedom from procedural related adverse events. There were no
7
device-related adverse events in any subject. The ReVene Thrombectomy Catheter performed as intended in all cases when used per the instructions for use. Note: Although this study evaluated the ReVene Thrombectomy Catheter in patients with DVT, the device is not indicated for treatment of DVT in the US.
Conclusion
Test results demonstrated that all acceptance criteria were met, and therefore, the device conforms to established product specifications and intended use. Based upon the technology, materials, intended use, non-clinical testing, and animal study results, it is concluded that the ReVene Thrombectomy Catheter is substantially equivalent to the predicate device. These results demonstrate that the ReVene Thrombectomy Catheter does not raise new questions of safety and effectiveness.