ZelanteDVT Thrombectomy Set

K151313 · Boston Scientific Corporation · QEW · Sep 21, 2015 · Cardiovascular

Device Facts

• Record ID: K151313
• Device Name: ZelanteDVT Thrombectomy Set
• Applicant: Boston Scientific Corporation
• Product Code: QEW · Cardiovascular
• Decision Date: Sep 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZelanteDVT™ Thrombectomy Set is intended for the removal of thrombus from and infusion of fluids into the peripheral vasculature.

Device Story

ZelanteDVT Thrombectomy Set is a component of the AngioJet Ultra Thrombectomy System; requires AngioJet Ultra Console for operation. Device uses high-velocity saline jets to create a low-pressure zone at the catheter tip; thrombus is drawn into the catheter, fragmented by jets, and evacuated through waste tubing to a collection bag. Catheter is 105 cm, introduced via 8F sheath, and tracks over a 0.035" guidewire. Manifold includes a port for contrast or fluid injection. Used in clinical settings by physicians to treat peripheral vascular thrombus. Benefits include mechanical thrombus removal and targeted infusion of thrombolytic agents, potentially restoring blood flow in patients with DVT or other peripheral venous occlusions.

Clinical Evidence

No human clinical data provided. Evidence consists of extensive nonclinical bench testing, including biocompatibility (cytotoxicity, sensitization, hemolysis, thromboresistance, pyrogenicity), and in vitro performance testing (clot removal, net evacuation, tensile strength, guidewire compatibility, pressure testing). Safety and performance were further evaluated in acute and chronic GLP animal studies in peripheral veins.

Technological Characteristics

Catheter-based thrombectomy system; 105 cm length; 8F introducer sheath compatible; 0.035" guidewire compatible. Operates via high-velocity saline jet (Bernoulli principle) to create low-pressure zone for thrombus aspiration. Includes manifold with stopcock for fluid/contrast injection. Sterilized device. System requires external AngioJet Ultra Console for saline delivery and vacuum generation.

Indications for Use

Indicated for use with AngioJet Ultra Console to break apart and remove thrombus, including DVT, from iliofemoral, lower extremity, and upper extremity peripheral veins ≥ 6.0 mm in diameter. Also indicated for controlled, selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system.

Regulatory Classification

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.

Predicate Devices

• Solent™ Omni Thrombectomy Set (K111182)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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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# 510(k) Summary

per 21 CFR §807.92

| Date Prepared | 15 May 2015 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Submitter's Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 |
| Contact Name and<br>Information | Anne V. Rossi<br>Regulatory Affairs Fellow<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name(s) | ZelanteDVT™ Thrombectomy Set |
| Common or Usual Name | Catheter, Embolectomy |
| Product Code | DXE |
| Secondary Product<br>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.

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# 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).