The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System in breaking apart and removing thrombus from infrainguinal peripheral arteries >=3.0 mm in diameter.

The AngioJet Power Pulse Spray Ancillary Kit is intended for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system using the Xpeedior 120 Catheter and the AngioJet System.

Device Description

The AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy System. The AngioJet System uses high velocity saline jets for percutaneous break-up and removal of thrombus. The 6 FR Catheter has a tapered flexible polymeric tip, and a large outflow lumen for guide wire passage and removal of thrombus debris. A small second lumen contained within the large outflow lumen supplies pressurized saline to the Catheter tip. The Catheter is designed to track over a 0.305" guide wire and through a guide catheter or sheath having an inner diameter of 0.086" or larger, with sufficient clearance to allow manual contrast injection, if desired. The Catheter connects to the AngioJet Pump Set and the multiple-use AngioJet Drive Unit (each packaged separately), which are necessary for operation of the AngioJet System.

The AngioJet Power Pulse Spray Ancillary Kit enables the AngioJet Xpeedior 120 Catheter to deliver a pulsed infusion of a physician-specified fluid to a local treatment area during a peripheral intervention. The Ancillary Kit also enables the Catheter to convert easily back to conventional AngioJet thrombectomy procedure.

The AngioJet Power Pulse Spray Ancillary Kit includes a Y-set that is comprised of two vented bag spikes bonded to PVC tubing with a clamp attached on each tube and a short, larger diameter section of PVC tubing bonded to a Y-junction. The Y-set is used to access the standard intravenous saline solution bag, used with AngioJet thrombectomy, and a second intravenous bag containing physician specified fluid. The tube clamps are used to control the flow of each fluid.

A separate one-way stopcock is included in the kit. This stopcock is placed between the Xpecdior 120 Catheters' outflow port, located on the underside of Catheter manifold, and the outflow tubing.

The Power Pulse Spray Ancillary Kit is an accessory that is to be used only with the AngioJet Rheolytic Thrombectomy System and Xpeedior 120 Catheter and will be packaged independent from the AngioJet System components (i.e. the Drive Unit, Pump Set, and Catheter.)

AI/ML Overview

The provided text is a 510(k) premarket notification for the AngioJet Xpeedior 120 Catheter and AngioJet Power Pulse Spray Ancillary Kit. This type of submission is for medical devices that are substantially equivalent to a predicate device, and it typically does not include detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as would be found in a De Novo or PMA submission.

Instead, the submission demonstrates substantial equivalence through functional and safety testing, material comparisons, and principles of operation to existing predicate devices.

Therefore, many of the requested details about acceptance criteria, specific study results, and ground truth establishment are not provided in this document.

However, based on the provided text, here's what can be extracted:

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

The document does not provide a table of explicit acceptance criteria with specific quantitative performance metrics. It states that "Representative samples of the device underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing, and animal testing to safety and effectiveness and to demonstrate appropriate functional and performance characteristics."

The "reported device performance" is essentially the finding of "substantial equivalence" to the predicate devices. The assumption is that the device performed equivalently to the predicate devices in the functional and safety tests, thus meeting implicitly defined performance characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Safety & Effectiveness (e.g., integrity, durability)	Demonstrated through bench testing
Biocompatibility	Demonstrated through bench testing
Sterility	Demonstrated through bench testing
Functional characteristics (e.g., thrombus removal, fluid infusion)	Demonstrated through comparative and animal testing
Equivalent to predicate devices in functional design, materials, indications for use, and principles of operation	Substantially equivalent to AngioJet LF140 Catheter (K972610), AngioJet Xpeedior 60 Catheter (K993564), AngioDynamics Power Pulsed Spray Infusion System (K905447 and K951509), and B.Braun Universal Spike Adaptor Y-Set (K780551).

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes used for the bench, comparative, or animal testing. It only refers to "Representative samples."
The data provenance is not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the submission is a 510(k) for substantial equivalence, not a clinical trial requiring expert ground truth in the context of diagnostic or treatment efficacy.

4. Adjudication method for the test set

This information is not provided.

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

No MRMC study was mentioned. This device is a catheter and ancillary kit, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable, as the device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) is not directly relevant here. The ground truth for this medical device's performance would be established by physical measurements, chemical analyses, and direct observation during the various safety and functional tests, along with comparison to the known performance of predicate devices.

8. The sample size for the training set

This is not applicable, as the device is not an AI algorithm that requires a training set.

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

This is not applicable.

Summary

{0}------------------------------------------------

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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 8, 2021

Possis Medical, Inc. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003

Re: K040013

Trade/Device Name: AngioJet Xpeedior 120 Catheter And AngioJet Power Pulse Spray Ancillary Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA

Dear Mark Stenoien:

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 May 18, 2004. 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,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08

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

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three flowing lines representing the head, body, and legs. The figure is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 2004

Possis Medical, Inc. c/o Mr. Mark Stenoien Manager, Clinical and Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003

Re: K040013

KU40013
Trade Name: AngioJet Xpeedior 120 Catheter and AngioJet Power Pulse Spray Ancillary Kit Regulation Numbers: 21 CFR 870.5150, 870.1210 Regulation Nambers: Embolectomy Catheter, Continuous Flush Catheter Regulatory Class: II (two) Product Codes: DXE, KRA Dated: March 31, 2004 Received: April 01, 2004

Dear Mr. Stenoien:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10(x) premainted is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave decemined the article predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the energions of the Federal Food. Drug. commerce prior to May 28, 1970, the enactinent with the provisions of the Federal Food, Drug, devices that have been reculted in accordance was as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval assessed sprovisions of the Act. The and Cosmetic Act (Act) that do not require approvate controls provisions of the Act. The
You may, therefore, market the device, subject to the enqual registration, listing You may, therefore, market the device, subject, subject on une legistration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirement misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it c If your device is classified (see above) mits end of regulations affecting your device can
may be subject to such additional controls. Existing major regulations allection, may be subject to such additional controlis. Existing in 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Peacharter concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 - Mr. Mark Stenoien

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualice of a substitive requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a decemmation that your and your recent agencies. You must or any Federal statules and regulations administered of not limited to: registration and listing (21 comply with all the Act s requirements, morades wantacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 200); 11 CFR 1000 105 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-10 product radiation control provisions (Dections 55 r device as described in your Section 510(k) This letter will anow you to begin harketing yobstantial equivalence of your device to a legally premarket nothication. The PDA midning of subscribed on thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific acvice for Jour at (301) 594-4646. Also, please note the regulation entitled, Contact the Office of Compulation at (301) >>Traction" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the succine broad Manufacturers, micemational and Goness http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duana R. Holmes

Co- Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known): K040013

Device Name: AngioJet Xpeedior 120 Catheter, and AngioJet Power Pulse Spray Ancillary Kit

Indications For Use:

The AngioJet Xpeedior 120 Catheter is intended for use with the AngioJet System 1. The Angloset Apeculor T20 Catherironmus from infrainguinal peripheral arteries >3.0 mm in diameter.
1. The AngioJet Power Pulse Spray Ancillary Kit is intended for the control and The Airer Fower False bpr specified fluids, including thrombolytic agents, into the peripheral vascular system using the Xpeedior 120 Catheter and the AngioJet System.

Prescription Use _ AND/OR X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dmna R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Ko40013

Page 1 of

Image /page/3/Picture/15 description: The image contains a handwritten digit '3'. The number is written in a simple, slightly slanted style. The digit is drawn with a smooth, continuous line, and the curves are well-defined.

{4}------------------------------------------------

SUMMARY AND CERTIFICATION SECTION 2.

510(k) SummaryA.
Submitter:	Possis Medical, Inc.
	9055 Evergreen Boulevard NW
	Minneapolis, MN 55433-8003 USA
Contact Person:	Mr. Mark Stenoien, Manager, Clinical & Regulatory Affairs
	9055 Evergreen Boulevard NW
	Minneapolis, MN 55433-8003 USA
	Phone: (763) 780-4555 Fax: (763) 780-2227
	Email: mark.stenoien@possis.com
Date Prepared:	31-Dec-2003
Trade Name:	The AngioJet Xpeedior 120 Catheter and the
	AngioJet Power Pulse Spray Ancillary Kit
Classification Name	AngioJet Xpeedior 120 Catheter is a class II device per 21 CFR
and Number:	870.5150 for peripheral use and the Power Pulse Spray Ancillary Kit
	is a class II devices as defined by 21 CFR 870.1210.
Product Code:	AngioJet Xpeedior 120 Catheter product code is DXE.
	AngioJet Power Pulse Spray Ancillary Kit product code is 74 KRA.
Predicate Device(s):	The AngioJet 120 Catheter is substantially equivalent to the devices
	listed below:
	• The AngioJet LF140 Catheter (K972610)
	• The AngioJet Xpeedior 60 Catheter (K993564).

	The AngioJet Power Pulse Spray Ancillary Kit is substantially
	equivalent to:
	• AngioDynamics Power Pulsed Spray Infusion System (K905447
	and K951509)
	• B.Braun Universal Spike Adaptor Y-Set (K780551).
Device Description:	The AngioJet Xpeedior 120 Catheter is a single-use component of
	the AngioJet Rheolytic Thrombectomy System. The AngioJetSystem uses high velocity saline jets for percutaneous break-up and
	removal of thrombus. The 6 FR Catheter has a tapered flexible
	polymeric tip, and a large outflow lumen for guide wire passage and
	removal of thrombus debris. A small second lumen contained within
	the large outflow lumen supplies pressurized saline to the Catheter
	tip. The Catheter is designed to track over a 0.305" guide wire and
	through a guide catheter or sheath having an inner diameter of 0.086"
	or larger, with sufficient clearance to allow manual contrast injection,
	if desired. The Catheter connects to the AngioJet Pump Set and the
	multiple-use AngioJet Drive Unit (each packaged separately), which
	are necessary for operation of the AngioJet System.
	The AngioJet Power Pulse Spray Ancillary Kit enables the AngioJet
	Xpeedior 120 Catheter to deliver a pulsed infusion of a physician-
	specified fluid to a local treatment area during a peripheral
		intervention. The Ancillary Kit also enables the Catheter to converteasily back to conventional AngioJet thrombectomy procedure.
		The AngioJet Power Pulse Spray Ancillary Kit includes a Y-set thatis comprised of two vented bag spikes bonded to PVC tubing with aclamp attached on each tube and a short, larger diameter section ofPVC tubing bonded to a Y-junction. The Y-set is used to access thestandard intravenous saline solution bag, used with AngioJetthrombectomy, and a second intravenous bag containing physicianspecified fluid. The tube clamps are used to control the flow of eachfluid.
		A separate one-way stopcock is included in the kit. This stopcock isplaced between the Xpecdior 120 Catheters' outflow port, located onthe underside of Catheter manifold, and the outflow tubing.
		The Power Pulse Spray Ancillary Kit is an accessory that is to beused only with the AngioJet Rheolytic Thrombectomy System andXpeedior 120 Catheter and will be packaged independent from theAngioJet System components (i.e. the Drive Unit, Pump Set, andCatheter.)
Intended Use:		The AngioJet Xpeedior 120 Catheter is intended for use with theAngioJet System in breaking apart and removing thrombus frominfrainguinal peripheral arteries ≥3.0 mm in diameter.
		The AngioJet Power Pulse Spray Ancillary Kit is intended for thecontrol and selective infusion of physician specified fluids, includingthrombolytic agents, into the peripheral vascular system using theXpeedior 120 Catheter and the AngioJet System.
Functional andSafety Testing:		Representative samples of the device underwent bench testing,including but not limited to mechanical testing, biocompatibility,sterility, comparative testing, and animal testing to safety andeffectiveness and to demonstrate appropriate functional andperformance characteristics.
Conclusion:		Possis Medical, Inc. considers the Xpeedior 120 Catheter and thePower Pulse Spray Ancillary Kit to be substantially equivalent to thepredicate devices listed above. This conclusion is based upon thedevices' similarities in functional design, materials, indications foruse and principles of operation.

{5}------------------------------------------------

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).