(57 days)
No
The summary describes a mechanical thrombectomy system that uses high-velocity saline jets and a helical rotation device to remove clots. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "Thrombectomy System" intended to "break apart and remove thrombus," which is a direct treatment for a medical condition (thrombosis). It also facilitates the "infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system," further indicating a therapeutic purpose.
No
Explanation: The device is described as a thrombectomy system intended to break apart and remove thrombus, and for controlled infusion of fluids. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly outlines physical components (Thrombectomy Set, ClotHunter Helical Rotation Device) and their mechanical functions (creating low-pressure zones, fragmenting thrombus, deflecting catheter tips). The performance studies also focus on physical and biological testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to physically break apart and remove thrombus from veins. This is an interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a system that uses pressurized saline jets and a helical rotation device to interact directly with the thrombus within the blood vessels. This is a mechanical and fluid-based intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) to diagnose a condition or provide information about a patient's health status. The device's function is purely therapeutic/interventional.
IVD devices are designed to be used in vitro (in glass, i.e., outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the living body).
N/A
Intended Use / Indications for Use
The ZelanteDVT™ Thrombectomy System, which includes the ZelanteDVT Thrombectomy Set and the ClotHunter Helical Rotation Device, is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
· Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
· Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy System is also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The ZelanteDVT™ Thrombectomy System is intended for removal of thrombus from and infusion of fluids into the peripheral vasculature
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA
Device Description
The AngioJet™ ZelanteDVT Thrombectomy System is a component of the AngioJet Ultra Thrombectomy System (AngioJet Ultra System or System). The ZelanteDVT Thrombectomy System can only be used in conjunction with the AngioJet Ultra Console. The AngioJet ZelanteDVT Thrombectomy System is comprised of the single-use ZelanteDVT Thrombectomy Set and the single-use ClotHunter Helical Rotation Device. Both components are packaged and sold separately. The ClotHunter Helical Rotation Device can only be used in conjunction with the ZelanteDVT Thrombectomy Set.
The Thrombectomy Set uses this pressurized, high-velocity saline to create a low-pressure zone at the Catheter tip. Thrombus is drawn into the Catheter where it is fragmented by the jets and evacuated from the body. The waste tubing transports the thrombus debris from the Catheter to the waste bag for ultimate disposal.
The ClotHunter Helical Rotation Device consists of a distal helical-shaped wire portion attached to a control handle that is used with the ZelanteDVT Thrombectomy Set. The Helical Rotation Device deflects the distal tip of the Catheter and improves clot removal due to increased luminal coverage. The ClotHunter Helical Rotation Device extends beyond the distal tip of the Catheter to provide a transition between the Catheter and the vessel wall.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Iliofemoral and lower extremity veins, Upper extremity peripheral veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Bench, animal, and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.
The following biocompatibility tests were completed on the ZelanteDVT ClotHunter Helical Rotation Device or leveraged from the reference device, the Amplatz Super Stiff Guidewire:
Cytotoxicity Extract and Direct Contact Hemolysis Sensitization Complement Activation Intracutaneous Reactivity Partial Thromboplastin Time Acute Systemic Toxicity In Vitro Hemocompatibility Materials Mediated Pyrogenicity Platelet and Leukocyte Counts
The following in-vitro performance tests were completed for the ZelanteDVT Thrombectomy System.
Clot Removal Wire Whip Force (Wire Torque) Catheter Withdrawal Infused Volume Handle Attach/Detach Radiopacity Distal Emboli Particulate Evaluation Catheter Advance Rotator Disengagement Force Insertion Force Rotational Fatigue Rotation Force Exposed Wire Length Wire Tip Tensile Wire Shape Retention Wire to Handle Torsional Force Trapped Wire Rotation Handle / Wire Tensile Strength Thumbwheel Breakage Gear Slip Force Column Strength Corrosion Handle Function Post Fluid Exposure Coating Integrity
Additionally a GLP animal study was performed to evaluate the safety and performance of the ZelanteDVT Thrombectomy System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 2, 2020
Boston Scientific Corporation Vanessa Fowler Senior Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311
Re: K202218
Trade/Device Name: ZelanteDVT™ Thrombectomy System ZelanteDVT™ ClotHunter™ Helical Rotation Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW, KRA Dated: August 5, 2020 Received: August 6, 2020
Dear Vanessa Fowler:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202218
Device Name
ZelanteDVT™ Thrombectomy System ZelanteDVT™ ClotHunter™ Helical Rotation Device
Indications for Use (Describe)
The ZelanteDVT Thrombectomy System, which includes the ZelanteDVT Thrombectomy Set and the ClotHunter Helical Rotation Device, is intended for use with the AngioJet Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:
· Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
· Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy System is also intended for use with the AngioJet Ultra Power Pulse technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
| 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
| Sponsor | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Vanessa Fowler
Sr Regulatory Affairs Specialist
3 Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-494-2537
Fax: 763-494-2222
e-mail: Vanessa.Fowler@bsci.com |
| Date Prepared | August 5, 2020 |
| Proprietary Name | ZelanteDVT™ Thrombectomy System
ZelanteDVT™ ClotHunter™ Helical Rotation Device |
| Common Name | Catheter, Embolectomy; Catheter, Continuous Flush |
| Product Code | QEW, KRA |
| Classification | Class II, 21 CFR Part 870.5150 |
| Predicate Device | ZelanteDVT Thrombectomy Set (K151313), cleared 21 September 2015 |
| Reference Device | Amplatz Super Stiff Guidewire (K843012), cleared 29 November 1984 |
| Device Description | The AngioJet™ ZelanteDVT Thrombectomy System is a component of the
AngioJet Ultra Thrombectomy System (AngioJet Ultra System or System).
The ZelanteDVT Thrombectomy System can only be used in conjunction with
the AngioJet Ultra Console. The AngioJet ZelanteDVT Thrombectomy
System is comprised of the single-use ZelanteDVT Thrombectomy Set and
the single-use ClotHunter Helical Rotation Device. Both components are
packaged and sold separately. The ClotHunter Helical Rotation Device can
only be used in conjunction with the ZelanteDVT Thrombectomy Set.
The Thrombectomy Set uses this pressurized, high-velocity saline to create a
low-pressure zone at the Catheter tip. Thrombus is drawn into the Catheter
where it is fragmented by the jets and evacuated from the body. The waste
tubing transports the thrombus debris from the Catheter to the waste bag for
ultimate disposal.
The ClotHunter Helical Rotation Device consists of a distal helical-shaped
wire portion attached to a control handle that is used with the ZelanteDVT
Thrombectomy Set. The Helical Rotation Device deflects the distal tip of the
Catheter and improves clot removal due to increased luminal coverage. The
ClotHunter Helical Rotation Device extends beyond the distal tip of the
Catheter to provide a transition between the Catheter and the vessel wall. |
| Intended Use of
Device | The ZelanteDVT™ Thrombectomy System is intended for removal of
thrombus from and infusion of fluids into the peripheral vasculature |
| Indications for Use | The ZelanteDVT Thrombectomy System, which includes the ZelanteDVT
Thrombectomy Set and the ClotHunter Helical Rotation Device, is intended
for use with the AngioJet Ultra Console to break apart and remove thrombus,
including deep vein thrombus (DVT), from:
• Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
• Upper extremity peripheral veins ≥ 6.0 mm in diameter.
The ZelanteDVT Thrombectomy System is also intended for use with the
AngioJet Ultra Power Pulse technique for the controlled and selective infusion
of physician specified fluids, including thrombolytic agents, into the peripheral
vascular system |
510(k) Summary for K202218 Per 21 CFR §807.92
4
| Comparison of
Technological
Characteristics | The ZelanteDVT Thrombectomy System incorporates substantially equivalent
device materials and design, packaging materials and design, fundamental
technology, manufacturing processes, sterilization process and intended use
as those featured in the ZelanteDVT Thrombectomy Set (K151313). |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | Bench, animal, and biocompatibility testing were performed to support a
determination of substantial equivalence. The results of these tests provide
reasonable assurance that the proposed device has been designed and
tested to assure conformance to the requirements for its intended use. No
new safety or performance issues were raised during the testing.
The following biocompatibility tests were completed on the ZelanteDVT
ClotHunter Helical Rotation Device or leveraged from the reference device,
the Amplatz Super Stiff Guidewire:
Cytotoxicity Extract and Direct Contact Hemolysis Sensitization Complement Activation Intracutaneous Reactivity Partial Thromboplastin Time Acute Systemic Toxicity In Vitro Hemocompatibility Materials Mediated Pyrogenicity Platelet and Leukocyte Counts The following in-vitro performance tests were completed for the ZelanteDVT
Thrombectomy System.
Clot Removal Wire Whip Force (Wire Torque) Catheter Withdrawal Infused Volume Handle Attach/Detach Radiopacity Distal Emboli Particulate Evaluation Catheter Advance Rotator Disengagement Force Insertion Force Rotational Fatigue Rotation Force Exposed Wire Length Wire Tip Tensile Wire Shape Retention Wire to Handle Torsional Force Trapped Wire Rotation Handle / Wire Tensile Strength Thumbwheel Breakage Gear Slip Force Column Strength Corrosion Handle Function Post Fluid Exposure Coating Integrity Additionally a GLP animal study was performed to evaluate the safety and |
AddRonally, a Jan ZelanteDVT Thrombectomy System.
5
| Conclusion | Based on the indications for use, technological characteristics, and safety and
performance testing, the ZelanteDVT Thrombectomy System, consisting of
the ZelanteDVT Thrombectomy Set and the ZelanteDVT ClotHunter Helical
Rotation Device, has been shown to be appropriate for its intended use and is
considered to be substantially equivalent to the ZelanteDVT Thrombectomy
Set (K151313). |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|