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.

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. 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. The physician-specified fluid is delivered using the AngioJet Ultra System, which includes the AngioJet Ultra Console and Thrombectomy Set.

AI/ML Overview

This document is a 510(k) summary for the AngioJet Ultra Power Pulse Kit. It describes the device, its intended use, and a comparison to a predicate device, as well as performance data.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "X% accuracy," "Y mm deviation"). Instead, it outlines the types of tests performed to demonstrate substantial equivalence to a predicate device. The "acceptance" is implied by the successful completion of these tests, confirming that the new device material (DEHP-free tubing) performs equivalently to the previous version.

Acceptance Criteria (Implied by testing)	Reported Device Performance
Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Physiochemical, Pyrogenicity, Hemolysis)	Passed/Conformed to ISO 10993 standards. (Verified new device material is substantially equivalent to predicate devices.)
Mechanical Integrity (Clamp open/close, Leak, Component separation)	Passed/Conformed to requirements. (Verified new device material is substantially equivalent to predicate devices.)
Functional Design Equivalence	Demonstrated similar functional design to the predicate.
Indications for Use Equivalence	Demonstrated same intended use as the predicate.
Principles of Operation Equivalence	Demonstrated similar principles of operation to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for the bench and laboratory testing. It just states that "Bench and laboratory testing was performed." There is no information about the country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not relevant or provided in this document. The testing described is primarily mechanical and biocompatibility, which typically relies on laboratory standards and instrumental measurements, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The testing did not involve expert adjudication in the context of clinical or diagnostic performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a catheter kit, not an AI-powered diagnostic system. No MRMC studies were conducted as part of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility testing, the "ground truth" would be established by the respective ISO 10993 standards and their defined limits for various biological responses. For mechanical integrity, the "ground truth" would be the engineering specifications and performance requirements for the device components (e.g., force required for clamp actuation, acceptable leak rates).

8. The sample size for the training set

Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services USA and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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, (301) 796-6075, Gregory.Oconnell@FDA.HHS.gov.

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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.9055 Evergreen Boulevard NWMinneapolis, MN 55433-8003 USA
Contact Person:	Amra RacicSenior Regulatory Affairs SpecialistPhone: (763) 450-8500Fax: (763) 780-2227Email: amra.racic@bayer.com
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:• 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.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.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:• Same intended use.• Same operating principle.• Same technological characteristics.• Same performance claims.
Performance Data:	This submission is a result of material modification to use DEHP free tubing.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
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.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).