ANGIOJET SOLENT DISTA THROMBECTOMY SET

K113363 · Medrad, Inc. · QEZ · Jun 6, 2012 · Cardiovascular

Device Facts

• Record ID: K113363
• Device Name: ANGIOJET SOLENT DISTA THROMBECTOMY SET
• Applicant: Medrad, Inc.
• Product Code: QEZ · Cardiovascular
• Decision Date: Jun 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from: - upper and lower extremity peripheral arteries > 1.5mm in diameter and - for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Device Story

Sterile, single-use thrombectomy catheter and pump unit; used with AngioJet Ultra Console. Operates via jet-based mechanical thrombectomy to break apart and remove thrombus from peripheral arteries. Also supports selective infusion of fluids/thrombolytics when used with AngioJet Ultra Power Pulse Kit. Used in clinical settings by physicians. Output is physical removal of thrombus and controlled fluid delivery. Benefits include restoration of blood flow in peripheral vasculature.

Clinical Evidence

Bench and laboratory testing performed. Biocompatibility testing per ISO 10993 (cytotoxicity, reactivity, sensitization, systemic toxicity, pyrogen, physiochemical). Hemocompatibility testing per ISO 10993-4 and ASTM F2382-04. Operational testing included leak, corrosion, dimensional verification, guide wire compatibility, particulate generation, tracking in tortuosity, extended use, clot removal, hemolysis, thermal dose, and mechanical integrity (tensile, compression, buckling, torque). GLP animal acute and chronic safety studies conducted.

Technological Characteristics

Sterile, single-use disposable catheter and pump unit. Materials tested for biocompatibility per ISO 10993 and hemocompatibility per ISO 10993-4/ASTM F2382-04. Operates via jet-based mechanical thrombectomy. Designed for use with AngioJet Ultra Console. Mechanical integrity verified via tensile, compression, buckling, and torque testing.

Indications for Use

Indicated for thrombus removal in upper and lower extremity peripheral arteries > 1.5mm diameter and for selective infusion of physician-specified fluids (including thrombolytics) in 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

• AngioJet Ultra Solent Omni Thrombectomy Set (K111182)
• AngioJet Ultra XMI Thrombectomy Set (K072769)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

February 8, 2021

Medrad. Inc. Mike Burnside Regulatory Affairs Manager 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433-8003

Re: K113363

Trade/Device Name: AngioJet Solent Dista Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Mike Burnside:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 06, 2012. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -5 O'connell -S Date: 2021.02.08 08:08:00 -05'00'

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

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

JUN - 6 2012

MEDRAD, Inc. c/o Mike Burnside Regulatory Affairs Manager 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

Re: K113363

Trade/Device Name: AngioJet Solent Dista Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: March 28, 2012 Received: April 11, 2012

Dear Mr. Burnside:

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. However, we remind you 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.

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## Page 2 - Mr. Mike Burnside

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.S. Helleber

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known): k113363

Device Name: AngioJet® Solent™ Dista Thrombectomy Set

### Indications for Use:

The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:

- upper and lower extremity peripheral arteries > 1.5mm in diameter and
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of . physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

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)

Cus A. Helle

of CDRH, Office of Device Evaluation (ODE) of Cardiovascular Devices

510(k) Numbe

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|< 113363

6 2012

| Section 5 - 510(k) Summary JUN - | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | MEDRAD, INC.<br>9055 Evergreen Boulevard NW<br>Minneapolis, MN 55433-8003 USA |
| Contact Person: | Mike Burnside<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | February 16, 2012 |
| Trade Name: | AngioJet® Solent™ Dista Thrombectomy Set |
| Classification: | 870.5150 and 870.1210 |
| Product Code: | DXE and KRA |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>• K111182 AngioJet Ultra Solent Omni Thrombectomy Set<br>• K072769 AngioJet Ultra XMI Thrombectomy Set |
| Device Description: | AngioJet Solent Dista Thrombectomy Set is a sterile, single use,<br>disposable set that includes a Thrombectomy Catheter and Pump in<br>one combined unit. The AngioJet Solent Dista Thrombectomy Set is<br>used with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Solent Dista Thrombectomy Set is intended for use with<br>the AngioJet Ultra Console to break apart and remove thrombus from:<br>• upper and lower extremity peripheral arteries ≥ 1.5mm in diameter and<br>• for use with the AngioJet Ultra Power Pulse Kit for the control<br>and selective infusion of physician specified fluids, including<br>thrombolytic agents, into the peripheral vascular system. |
| Comparison to predicate: | Design changes were made to the predicate device which included:<br>change in length of device, changes to the jet body, changes to<br>catheter shaft, changes to distal section of catheter, and changes to<br>diameter of catheter. |
| Performance Data | Bench and laboratory testing was performed to support a<br>determination of substantial equivalence to the predicate device.<br>Results from the testing provide assurance that the proposed device<br>conforms to the requirements for its intended use. This included the<br>following testing:<br>• Biocompatibility<br>o Cytotoxicity (ISO 10993-5)<br>o Intracutaneous Reactivity (ISO 10993-10)<br>o Sensitization (ISO 10993-10)<br>o Acute Systemic Toxicity (ISO 10993-11)<br>o Material Mediated Pyrogen (ISO 10993-11) |

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- o Physiochemical (ISO 10993-18)
- Hemocompatibility o
- ASTM Hemolysis (ISO 10993-4)
- · Partial Thromboplastin Time Assay (ASTM F2382-04)
- · C3a Complement Activation (ISO 10993-4)
- · SC5b-9 Complement Activation (ISO 10993-4)
- · Thromboresistance (ISO 10993-4)
- Catheter operational characteristics .
- Leak testing .
- Corrosion .
- Dimensional verification 0
- . Guide wire compatibility tests
- Particulate generation
- Tracking/function in tortuosity .
- . Extended use
- . Clot removal
- Hemolysis .
- Thermal dose .
- Mechanical integrity (tensile strengths, compression / . buckling, torque testing)
- . GLP Animal acute and chronic safety studies.

# Conclusion:

MEDRAD considers the AngioJet Solent Dista Thrombectomy Set to be substantially equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and principles of operation. Testing (bench, biocompatibility testing, and animal testing) verified that the new device is substantially equivalent to the predicate devices.