ANGIOJET ULTRA POWER PULSE KIT

K130381 · Medrad, Inc. · QEW · Jul 29, 2013 · Cardiovascular

Device Facts

• Record ID: K130381
• Device Name: ANGIOJET ULTRA POWER PULSE KIT
• Applicant: Medrad, Inc.
• Product Code: QEW · Cardiovascular
• Decision Date: Jul 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AngioJet® Ultra Power Pulse Kit is intended for use only with the AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System.

Device Story

AngioJet Ultra Power Pulse Kit is an accessory for the AngioJet Ultra Thrombectomy System; enables pulsed infusion of physician-specified fluids (e.g., thrombolytics) into peripheral vasculature. Kit consists of Y-set with vented bag spikes and tubing clamps; connects to standard saline bag and secondary fluid bag. Physician operates system via AngioJet Ultra Console to control fluid delivery. Device facilitates local treatment of thrombi; provides targeted drug delivery to improve clinical outcomes in peripheral vascular interventions.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-5, -10, -11, -18, -4) and mechanical integrity (clamp function, leak testing, component separation) to verify performance of DEHP-free tubing material.

Technological Characteristics

Y-set configuration with vented bag spikes and tubing clamps. Materials modified to be DEHP-free. Operates as a fluid delivery accessory for the AngioJet Ultra System. No electronic components or software.

Indications for Use

Indicated for control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system in patients requiring thrombectomy via the AngioJet Ultra 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® Xpeedior® 120 Catheter (K052256)

Submission Summary (Full Text)

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July 27, 2020

Medrad, Inc. Amra Racic Senior Regulatory Affairs Specialist 9055 Evergreen Blvd Nw Minneapolis, Minnesota 55433-8003

Re: K130381

Trade/Device Name: Angiojet Ultra Power Pulse Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW

Dear Amra Racic:

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 July 29, 2013. Specifically, FDA is updating this SE Letter 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], [e-mail].

Sincerely.

Gregory W.
O'connell -S
Digitally signed by Gregory
W. O'connell -S
Date: 2020.07.27 08:02:16
-04'00'

Gregory O'Connell Assistant Director Plaque Modification Devices Team 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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Public Health Service

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

July 29, 2013

MEDRAD, INC. c/o Amra Racic Senior Regulatory Affairs Specialist 9055 Evergreen Boulevard NW Minneapolis, MN 55433

Re: K130381

Trade/Device Name: AngioJet® Ultra Power Pulse® Kit Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: May 30, 2013 Received: May 31, 2013

Dear Ms. Racic:

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,

# Bram D. Zuckerman -S

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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### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AngioJet® Ultra Power Pulse® Kit

#### Indications for Use:

The AngioJet® Ultra Power Pulse Kit is intended for use only with the AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Bram D. Zuckerman -S 2013.07.29 18:16:15 -04'00

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## Section 5 – 510(k) Summary

| Submitter: | MEDRAD, INC.<br>9055 Evergreen Boulevard NW<br>Minneapolis, MN 55433-8003 USA |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amra Racic<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | February 13, 2013 |
| Trade Name: | AngioJet® Ultra Power Pulse® Kit |
| Classification: | 870.1210 |
| Product Code: | KRA |
| Predicate Device(s): | The subject device is equivalent to the following device:<br>• K052256 AngioJet® Xpeedior® 120 Catheter |
| Device Description: | AngioJet Ultra Power Pulse Kit enables the AngioJet Ultra Thrombecomy Set to deliver a pulsed infusion of physician-specified fluid to a local treatment area. The AngioJet Ultra Power Pulse Kit includes a Y-set with vented bag spikes that are bonded to tubing. Each upper arm of the Y-tubing contains a tubing clamp, one white and one red.<br><br>The vented bag-spikes are used to access the standard intravenous saline solution bag used with the AngioJet Ultra System and a second intravenous bag, containing physician-specified fluid. The tube clamps are used to control the flow of the two fluids.<br><br>The physician-specified fluid is delivered using the AngioJet Ultra System, which includes the AngioJet Ultra Console and Thrombectomy Set. |
| Intended Use: | The AngioJet Ultra Power Pulse Kit is intended for use only with AngioJet Ultra Thrombectomy Sets indicated for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system using the AngioJet Ultra System. |
| Comparison to predicate: | A comparison of the modified device and the currently marketed AngioJet Power Pulse Kit show the following similarities:<br>• Same intended use.<br>• Same operating principle.<br>• Same technological characteristics.<br>• Same performance claims. |
| Performance Data: | This submission is a result of material modification to use DEHP free tubing.<br>Bench and laboratory testing was performed to support a determination of substantial equivalence to the predicate device.<br>Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the |
| MEDRAD, INC. | Page 1 of 2 |

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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
- Physiochemical (ISO 10993-18) O
- Pyrogenicity (ISO 10993-11) O
- Hemolysis (ISO 10993-4) O
- Mechanical integrity ●
- Clamp open/close O
- Leak o
- Component separation O

#### Conclusion: MEDRAD, Inc. considers the AngioJet Ultra Power Pulse Kit to be substantially equivalent to the predicate device listed above. This conclusion is based upon the device similarities in functional design, indications for use, and principles of operation. Mechanical and Biocompatibility Testing summarized in Tables 2 and 3, verified that the new device material is substantially equivalent to the predicate devices.