(126 days)
No
The summary describes a mechanical thrombectomy device that uses high-velocity saline jets to fragment and remove thrombus. There is no mention of AI, ML, image processing, or any other computational technology that would suggest the use of AI/ML. The performance studies focus on mechanical and biological properties, not algorithmic performance.
Yes
The device is described as being "intended for the removal of thrombus from and infusion of fluids into the peripheral vasculature," specifically to "break apart and remove thrombus, including deep vein thrombus (DVT)." This directly addresses a medical condition (thrombus formation) with a therapeutic action (removal).
No
The device is designed for the removal of thrombus and infusion of fluids, which are therapeutic actions, not diagnostic ones. It performs an intervention directly on the thrombus rather than assessing or identifying a medical condition.
No
The device description clearly indicates the ZelanteDVT™ Thrombectomy Set is a physical component (catheter, manifold, waste tubing) intended for use with a separate hardware console (AngioJet® Ultra Console) to perform a physical procedure (thrombus removal and fluid infusion). It is not solely software.
Based on the provided information, the ZelanteDVT™ Thrombectomy Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The ZelanteDVT™ Thrombectomy Set is a medical device used within the body (in vivo) to physically remove thrombus (blood clots) from blood vessels. It is a therapeutic device, not a diagnostic one.
The description clearly states its intended use is for "removal of thrombus from and infusion of fluids into the peripheral vasculature" and describes a mechanical process of breaking apart and evacuating thrombus. This is a direct intervention on the patient's circulatory system, not an analysis of a sample taken from the patient.
N/A
Intended Use / Indications for Use
The ZelanteDVT™ Thrombectomy Set 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 Set 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.
Product codes
DXE, KRA
Device Description
The ZelanteDVT™ Thrombectomy Set is one component of the AngioJet® Ultra Thrombectomy System (AngioJet Ultra System). The other component, packaged and sold separately, is the multiple-use AngioJet® Ultra Console. The ZelanteDVT Thrombectomy Set can only be used in conjunction with the AngioJet Ultra Console.
The ZelanteDVT Thrombectomy Set uses 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 collection bag for ultimate disposal.
The 105 cm ZelanteDVT Thrombectomy Catheter is introduced through an 8F introducer sheath and tracks and operates over a 0.035" (0.89 mm) guidewire. The manifold is equipped with a port with an attached stopcock. This port can be used to inject contrast media and other fluids into the bloodstream.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and Upper extremity peripheral veins ≥ 6.0 mm in diameter.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Nonclinical testing was performed on the ZelanteDVT Thrombectomy Set 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 device testing.
The following biocompatibility tests were completed on the ZelanteDVT Thrombectomy Set:
Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Direct Contact Hemolysis, In Vitro Hemocompatibility, In Vivo Thromboresistance, Materials Mediated Pyrogenicity, USP Physicochemical.
The following in vitro performance tests were completed with the ZelanteDVT Thrombectomy Set:
Shaft Outer Diameter, Effective Length, Guidewire Compatibility, Operating Pressure, Net Evacuation, Infusion Rate, Particulate, Clot Removal, Hemolysis Ratio, Contrast Injection, Extended Use, Thermal Dose, Torque Transference, Corrosion & FM, Freedom from Leaks, Guidewire Lumen Leak, Device Tensile, Tip Compression, Manifold Torque, Torsional Buckling Strength, Proximal Saddle Torque, Manifold Fluid Immersion, U-Bend, Distal Pressure Test, Packaging Bubble and Peel Tests.
Additionally Acute and Chronic GLP studies were performed to evaluate the safety and performance of the ZelanteDVT Thrombectomy Set in peripheral veins.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them that resemble hair or a stylized representation of the human spirit.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2015
Boston Scientific Corporation c/o Ms. Anne V. Rossi Regulatory Affairs Manager One Scimed Place Maple Grove. MN 55311
Re: K151313
Trade/Device Name: ZelanteDVT Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Catheter, Embolectomy Regulatory Class: Class II Product Code: DXE, KRA Dated: August 21, 2015 Received: August 24, 2015
Dear Ms. Rossi:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
of Surveillance and Biometrics/Division of Postmarket Surveillance.
Sincerely yours,
Kenneth J. Cavanaugh -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K151313
Device Name ZelanteDVT™ Thrombectomy Set
Indications for Use (Describe)
The ZelanteDVT™ Thrombectomy Set 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 Set 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
510(k) Summary
per 21 CFR §807.92
| Date Prepared | 15 May 2015 |
|---|---|
| Submitter's Name and | |
| Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311 | |
| Contact Name and | |
| Information | Anne V. Rossi |
| Regulatory Affairs Fellow | |
| Phone: 763-494-1094 | |
| Fax: 763-494-2222 | |
| Email: Anne.Rossi@bsci.com | |
| Trade Name(s) | ZelanteDVT™ Thrombectomy Set |
| Common or Usual Name | Catheter, Embolectomy |
| Product Code | DXE |
| Secondary Product | |
| Code | KRA (Catheter, Continuous Flush) |
| Classification of Device | Class 2 according to 21 CFR 870.5150 |
| Predicate Device(s) | Solent™ Omni Thrombectomy Set K111182 24 May 2011 |
Device Description
The ZelanteDVTT™ Thrombectomy Set is one component of the AngioJet® Ultra Thrombectomy System (AngioJet Ultra System). The other component, packaged and sold separately, is the multiple-use AngioJet® Ultra Console. The ZelanteDVT Thrombectomy Set can only be used in conjunction with the AngioJet Ultra Console.
The ZelanteDVT Thrombectomy Set uses 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 collection bag for ultimate disposal.
The 105 cm ZelanteDVT Thrombectomy Catheter is introduced through an 8F introducer sheath and tracks and operates over a 0.035" (0.89 mm) guidewire. The manifold is equipped with a port with an attached stopcock. This port can be used to inject contrast media and other fluids into the bloodstream.
Intended Use
The ZelanteDVT™ Thrombectomy Set is intended for the removal of thrombus from and infusion of fluids into the peripheral vasculature.
4
Indications for Use
The ZelanteDVTT™ Thrombectomy Set 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 Set 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.
Comparison of Required Technological Characteristics
The ZelanteDVT Thrombectomy Set incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate AngioJet Solent Omni Thrombectorny Set (K111182).
Summary of Nonclinical Tests
Nonclinical testing was performed on the ZelanteDVT Thrombectomy Set 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 device testing.
The following biocompatibility tests were completed on the ZelanteDVT Thrombectomy Set:
| Cytotoxicity | Acute Systemic Toxicity | In Vivo Thromboresistance |
|---|---|---|
| Sensitization | Direct Contact Hemolysis | Materials Mediated Pyrogenicity |
| Intracutaneous Reactivity | In Vitro Hemocompatibility | USP Physicochemical |
The following in vitro performance tests were completed with the ZelanteDVT Thrombectomy Set:
| Shaft Outer Diameter | Hemolysis Ratio | Device Tensile |
|---|---|---|
| Effective Length | Contrast Injection | Tip Compression |
| Guidewire Compatibility | Extended Use | Manifold Torque |
| Operating Pressure | Thermal Dose | Torsional Buckling Strength |
| Net Evacuation | Torque Transference | Proximal Saddle Torque |
| Infusion Rate | Corrosion & FM | Manifold Fluid Immersion |
| Particulate | Freedom from Leaks | U-Bend |
| Clot Removal | Guidewire Lumen Leak | Distal Pressure Test |
| Packaging Bubble and Peel Tests |
Additionally Acute and Chronic GLP studies were performed to evaluate the safety and performance of the ZelanteDVT Thrombectomy Set in peripheral veins.
Conclusion
Based on the indications for use, technological characteristics, safety and performance testing, the ZelanteDVT Thrombectomy Set is appropriate for the intended use and is considered to be substantially equivalent to the AngioJet Solent Omni Thrombectomy Set (K111182).