ANGIOJET ULTRA AVX THROMBECTOMY SET

K133629 · Possis Medical, Inc. · QEW · Feb 14, 2014 · Cardiovascular

Device Facts

• Record ID: K133629
• Device Name: ANGIOJET ULTRA AVX THROMBECTOMY SET
• Applicant: Possis Medical, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Feb 14, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.

Device Story

The AngioJet Ultra AVX Thrombectomy Set is a sterile, single-use, disposable catheter and pump unit designed for use with the AngioJet Ultra Console. It functions by breaking apart and removing thrombus from A-V access conduits. The device is operated by a clinician in a clinical setting. It utilizes mechanical thrombectomy principles to clear obstructions, potentially benefiting patients by restoring patency to their A-V access. The system is a modification of the predicate device, featuring changes to the manifold color, waste bag tubing, bubble trap, manifold bonds, strain relief, and waste bag-to-tube connection.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, material-mediated pyrogen, and physiochemical) and design verification (operation pressure, net evacuation, infusion rate, extended use, dimensional testing, system leak testing, contrast injection, guide wire passage, and mechanical integrity) at zero time and after 2 years of accelerated aging.

Technological Characteristics

Sterile, single-use, disposable thrombectomy catheter and pump unit. Materials evaluated per ISO 10993 standards. Operates via mechanical thrombectomy principle in conjunction with the AngioJet Ultra Console. Connectivity is system-specific to the console. No software or electronic algorithm components described.

Indications for Use

Indicated for patients requiring thrombus removal from A-V access conduits with a diameter of 3 mm or greater.

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

• AngioJet Ultra AVX Thrombectomy Set (K082382)

Submission Summary (Full Text)

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K133629 p. 1 of 2

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## Section 5 – 510(k) Summary

| Submitter: | MEDRAD, INC.<br>9055 Evergreen Boulevard NW<br>Minneapolis, MN 55433-8003 USA | FEB 14 2014 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | George Lucas<br>Sr. Regulatory Affairs Associate<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Prepared: | November 25, 2013 | |
| Trade Name: | AngioJet® Ultra AVX® Thrombectomy Set | |
| Classification: | 870.5150 | |
| Product Code: | DXE | |
| Predicate Device(s): | The subject device is equivalent to the following device:<br>• K082382 AngioJet Ultra AVX Thrombectomy Set | |
| Device Description: | AngioJet Ultra AVX Thrombectomy Set is a sterile, single use,<br>disposable set that includes a Thrombectomy Catheter and Pump in<br>one combined unit. The AngioJet Ultra AVX Thrombectomy Set is<br>used with the AngioJet Ultra Console. | |
| Intended Use: | AngioJet Ultra AVX Thrombectomy Set is intended for use with the<br>AngioJet Ultra System in breaking apart and removing thrombus from<br>A-V Access conduits ≥ 3 mm in diameter. | |
| Comparison to predicate: | Change to the color of the manifold from yellow to smoke grey. In<br>addition, design changes were made to the predicate device that<br>included: change in waste bag tubing, change in bubble trap, change<br>in glue for manifold bonds, change in manifold strain relief, and<br>change in waste bag to tube connection. | |

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Performance Data Bench and laboratory testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:

- Biocompatibility Testing .
- o Cytotoxicity (ISO 10993-5)
- O Sensitization (ISO 10993-10)
- Intracutaneous Reactivity (ISO 10993-10) o
- Acute Systemic Toxicity (ISO 10993-11) o
- o ASTM Hemolysis (ISO 10993-4)
- Material Mediated Pyrogen (ISO 10993-11) o
- o Physiochemical (ISO 10993-18)
- . Design Verification Testing at zero time and at 2 years of accelerated aging.
- O Operation Pressure
- O Net Evacuation
- O Infusion rate
- Extended Use o
- Dimensional testing o
- System leak testing o
- o Contrast Injection
- Guide Wire Passage o
- O Mechanical Integrity testing
- Conclusion: MEDRAD considers the AngioJet Ultra AVX Thrombectomy Set to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2014

MEDRAD, Inc. Mr. George Lucas Senior Regulatory Affairs Associate 9055 Evergreen Blvd., N.W. Minneapolis, MN 55433-8003

K133629 Re:

> Trade/Device Name: AngioJet Ultra AVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: January 14, 2014 Received: January 15, 2014

Dear Mr. Lucas,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Mr. George Lucas

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" (21 CFR 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 of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

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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K133629

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AngioJet® Ultra AVX® Thrombectomy Set

Indications for Use:

The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.

Prescription Use X (Part 21 CFR 801 Subpart D)

·

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kenneth J. Cavanaugh -S