ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001

K101406 · Medrad Interventional/Possis · QEZ · Jun 16, 2010 · Cardiovascular

Device Facts

• Record ID: K101406
• Device Name: ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001
• Applicant: Medrad Interventional/Possis
• Product Code: QEZ · Cardiovascular
• Decision Date: Jun 16, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioJet Solent Proxi Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from : upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, . upper extremity peripheral veins ≥ 3.0mm in diameter, . ileofemoral and lower extremity veins ≥ 3.0mm in diameter, . A-V access conduits ≥ 3.0mm 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 by breaking apart and removing thrombus from peripheral vasculature; also supports selective infusion of fluids/thrombolytics via AngioJet Ultra Power Pulse Kit. Used by physicians in clinical settings. Provides mechanical thrombus removal; benefits patients by restoring blood flow in peripheral vessels and A-V access conduits.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5, -10, -11, -18, -4), hemocompatibility (ASTM F2382-04), leak testing, guide wire compatibility, particulate generation, tracking, extended use, kink resistance, corrosion, clot removal, hemolysis, catheter pass wall temperature, and mechanical integrity (tensile/compression/buckling).

Technological Characteristics

Sterile, single-use disposable catheter and pump unit. Employs mechanical thrombectomy principle. Materials tested per ISO 10993 standards. Compatible with AngioJet Ultra Console and Power Pulse Kit. Features include modified catheter shaft, manifold, and tip for guide wire usage.

Indications for Use

Indicated for thrombus removal in peripheral arteries, peripheral veins, ileofemoral veins, and A-V access conduits ≥ 3.0mm in diameter; also indicated for selective infusion of physician-specified fluids (including thrombolytics) 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

• AngioJet Ultra DVX and Xpeedior Thrombectomy Sets (K091593)

Submission Summary (Full Text)

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May 20, 2021

MEDRAD Interventional/Possis Doug Atkins Sr. Regulatory Affairs Associate 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433

Re: K101406

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

Dear Doug Atkins:

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 16, 2010. 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 regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone]. Gregory. Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.05.20

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 3 2010

MEDRAD Interventional / Possis c/o Mr. Doug Atkins Senior Regulatory Affairs Associate 9055 Evergreen Boulevard Minneapolis, MN 55433-8003

Re: K101406

Angiojet Solent Proxi Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: May 18, 2010 Received: May 19, 2010

Dear Mr. Atkins:

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

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Page 2 - Mr. Doug Atkins

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 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/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 vours.

R. Vihner

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): K101406

Device Name: AngioJet® Solent™ Proxi Thrombectomy Set

### Indications for Use:

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

- upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
- upper extremity peripheral veins ≥ 3.0mm in diameter, .
- ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
- A-V access conduits ≥ 3.0mm 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)

| (Division Sign-Off) | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------------|--------------------------------------------------------|
| Division of Cardiovascular Devices | |

510(k) Number K101406

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K101406

JUN 1 3 2010

# Section 5 – 510(k) Summary

| Submitter: | MEDRAD Interventional / Possis<br>9055 Evergreen Boulevard NW<br>Minneapolis, MN 55433-8003 USA |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Doug Atkins<br>Sr. Regulatory Affairs Associate<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | June 15, 2010 |
| Trade Name: | AngioJet® Solent™ Proxi 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>K091593 AngioJet Ultra DVX and Xpeedior Thrombectomy Sets |
| Device Description: | AngioJet Solent Proxi 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 Proxi Thrombectomy Set is<br>used with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Solent Proxi 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 ≥ 3.0mm in<br>diameter,<br>upper extremity peripheral veins ≥ 3.0mm in diameter,<br>ileofemoral and lower extremity veins ≥ 3.0mm in diameter, |
| | A-V access conduits ≥ 3.0mm 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<br>predicate: | Design changes were made to the predicate device which included:<br>changes to the catheter shaft design, changes to the catheter manifold<br>and tip to facilitate guide wire usage, and a change to the strain relief /<br>manifold joint. |

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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
- Cytotoxicity (ISO 10993-5) o
- Intracutaneous Reactivity (ISO 10993-10) o
- Sensitization (ISO 10993-10) O
- Acute Systemic Toxicity (ISO 10993-11) o
- Material Mediated Pyrogen (ISO 10993-11) O
- 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 ●
- Guide wire compatibility tests .
- Particulate generation .
- . Tracking
- . Extended use
- Kink resistance .
- . Corrosion
- Clot removal .
- . Hemolysis
- Catheter pass wall temperature .
- . Mechanical integrity (tensile strengths and compression / buckling)

#### Conclusion:

MEDRAD Interventional / Possis considers the AngioJet Solent Proxi 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.