The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is intended for breaking apart and removing thrombus from A-V access conduits when used with the AngioJet System.

Device Description

The AngioJet XPEEDIOR Catheter is designed for operation with the AngioJet Rheolytic Thrombectomy System (AngioJet System). The AngioJet System consists of three components: the Drive Unit, disposable Pump Set, and disposable Catheter.

The AngioJet XPEEDIOR Catheter is a new AngioJet catheter model which has been designed to optimize clot removal performance. As with other AngioJet Catheter models the XPEEDIOR Catheter consists of a manifold, Catheter body, and tip. The manifold contains connections for the high pressure saline supply, an exhaust removal line, and a hemostasis valve for sealing around an 0.035" and smaller diameter guidewire. The Catheter body consists of a stainless steel hypodermic tube extending the length of the catheter which carries high pressure saline to the tip. This tube lies within a single lumen polymeric tube which serves as a lumen for both exhaust and guidewire. The tip contains the portion of the hypotube which has been formed into a toroidal loop. Six small holes are located on the proximal portion of the loop. Jets of saline exit these holes at high velocity and are directed proximally from the tip. These jets flow past a primary set of orifices in the exhaust tube referred to as inflow windows. Thrombus is entrained (via the Bernoulli effect of high velocity creating a vacuum) into these windows and then macerated. The thrombotic debris is propelled by the dynamic pressure of the jets through the exhaust lumen and out of the manifold body to the exhaust bag. A set of secondary orifices referred to as outflow windows are positioned in the exhaust tube proximal to the inflow windows. These aid in recirculating and breaking up the thrombus. The outflow windows are the primary new feature compared to previous AngioJet Catheter models except for the F105, in which 3 low-pressure, radially directed jets were employed. Fluid, which is powered by the dynamic pressure of the jets, flows from these outflow windows and then back to the inflow windows. This recirculation pattern improves the efficacy of the device by increasing the volume of the entrainment zone while still maintaining a minimal catheter profile.

AI/ML Overview

The provided text is a 510(k) summary for the AngioJet XPEEDIOR Catheter, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results or acceptance criteria in the way a clinical trial or AI/ML device submission would.

Therefore, many of the requested categories of information are explicitly not present in this document because they are not typically required for a 510(k) of this nature. The document explicitly states that "Extensive in vitro, physical, functional, animal, and biocompatibility tests have been performed on the XPEEDIOR Catheter. These tests have shown that the XPEEDIOR Catheter performs comparably to the predicate device. All performance results for the XPEEDIOR Catheter and the predicate device exceed physiological requirements for the intended clinical use of the device." This indicates that the "acceptance criteria" here are largely based on meeting performance requirements comparable to the predicate for safety and effectiveness through non-clinical testing.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding "reported device performance" in the format one might expect for a new AI/ML diagnostic or therapeutic device. Instead, the "acceptance criteria" are implied to be comparability to the predicate device (AngioJet LF140 Catheter) in non-clinical performance, and exceeding physiological requirements for intended clinical use.

The "reported device performance" is summarized qualitatively: "All performance results for the XPEEDIOR Catheter and the predicate device exceed physiological requirements for the intended clinical use of the device."

The comparison table provided (Table 1) focuses on technical characteristics rather than specific performance metrics (like clot removal rate, safety endpoints, etc.).

Characteristic	Predicate Device (LF140 Catheter)	Subject Device (XPEEDIOR Catheter)
Application	Thrombus removal in AV access grafts	Thrombus removal in AV access grafts
Intended Guidewire	0.018"	0.035"
Materials	Same	Same
Working Length	140cm	60cm
Maximum Shaft Diameter	5 Fr	6 Fr
Flexibility	Enhanced	Standard
Exhaust Tubing	6333 Dual Lumen Pebax	5333 Single Lumen Pebax
Tip Style	Stainless Steel Cap	Polymeric Tapered Flexible
Gap length	0.018"	gap replaced with inflow and outflow windows
Drive Unit Operating Mode	Mode 2- 50cc/min	Mode 1- 60cc/min
Number of Jets	6	6
Operating Pressure	7-12 Kpsi	7-12 Kpsi
Performance	"exceed physiological requirements" (implied comparable)	"exceed physiological requirements"
Comparability	n/a	Performs comparably to predicate

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

Not applicable/Not provided. This document describes non-clinical (in vitro, physical, functional, animal, and biocompatibility) tests, not a clinical study with a "test set" of patient data.

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

Not applicable/Not provided. This is not a study involving expert-derived ground truth for a diagnostic algorithm.

4. Adjudication method for the test set

Not applicable/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

Not applicable. This is not for an AI/ML device, nor does it describe a clinical comparative effectiveness study involving human readers.

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

Not applicable. This is not an AI/ML algorithm. The device performance (thrombus removal) is assessed through non-clinical testing.

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

Not applicable/Not explicitly detailed. For non-clinical tests, "ground truth" would be the known physical properties, functional outcomes (e.g., amount of clot removed in an in vitro model), or safety endpoints in animal studies, established by standard scientific measurement and observation.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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APR 2 8 2000

K993564

ANGIOJET® XPEEDIOR™ CATHETER 510(K) SUMMARY

APRIL 2000

SUBMITTER'SINFORMATION	Possis Medical, Inc.9055 Evergreen Boulevard N.W.Minneapolis, MN 55433Tel: (612) 780-4555Fax: (612) 780-2227
CONTACT	Primary
	Timothy J. KappersSupervisor, Regulatory Affairs & Compliance
	Alternate
	James D. GustafsonVice President of Quality Systemsand Regulatory/Clinical Affairs
SUMMARY DATE	April 18, 2000
DEVICE TRADE NAME	AngioJet XPEEDIOR Catheter
COMMON NAME	Thrombetomy/Embolectomy Catheter
DEVICE CLASS	Class II
LEGALLY MARKETEDPREDICATE DEVICE	AngioJet LF140 Catheter

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DEVICE DESCRIPTION

INTENDED USE

The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is intended for breaking apart and removing thrombus from A-V access conduits when used with the AngioJet System.

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COMPARISON TO PREDICATE DEVICE

Table 1 summarizes key technical characteristics and physical properties of the AngioJet XPEEDIOR Catheter and the predicate device (the AngioJet LF140 Catheter).

	LF140 Catheter	XPEEDIOR Catheter
Application	Thrombus removal in AVaccess grafts	Thrombus removal in AVaccess grafts
Intended Guidewire	0.018"	0.035"
Materials	Same	Same
Working Length	140cm	60cm
Maximum Shaft Diameter	5 Fr	6 Fr
Flexibility	Enhanced	Standard
Exhaust Tubing	6333 Dual Lumen Pebax	5333 Single Lumen Pebax
Tip Style	Stainless Steel Cap	Polymeric Tapered Flexible
Gap length	0.018"	gap replaced with inflowand outflow windows
Drive Unit Operating Mode	Mode 2- 50cc/min	Mode 1- 60cc/min
Number of Jets	6	6
Operating Pressure	7-12 Kpsi	7-12 Kpsi

TABLE 1 Comparison of Technical Characteristics

NON-CLINICAL TESTS

Extensive in vitro, physical, functional, animal, and biocompatibility tests have been performed on the XPEEDIOR Catheter. These tests have shown that the XPEEDIOR Catheter performs comparably to the predicate device. All performance results for the XPEEDIOR Catheter and the predicate device exceed physiological requirements for the intended clinical use of the device.

CONCLUSION

The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is intended for breaking apart and removing thrombus from A-V access conduits when used with the AngioJet System. The present 510(k) compares the XPEEDIOR Catheter to a legally marketed predicate device. The intended use, catheter configuration, material, labeling, method of use, intended anatomical sites, and the target population of the XPEEDIOR Catheter are the same as those of the predicate device.

There are no significant technological differences between the subject device and the predicate device.

As summarized above, this 510(k) notification provides adequate information to support a determination of substantial equivalence between the XPEEDIOR Catheter and its predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2000

Mr. Timothy J. Kappers Supervisor, Regulatory Affairs & Compliance Possis Medical, Inc. 9055 Evergreen Boulevard N.W. Minneapolis, MN 55433

K993564 Re: Possis AngioJet® X-STREAM™ Rheolytic Thrombectomy Catheter Regulatory Class: II (two) Product Code: MCW February 3, 2000 Dated: Received: February 4, 2000

Dear Mr. Kappers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Timothy J. Kappers

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Chistman Aranta

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ANGIOJET® XPEEDIOR™ CATHETER INDICATION FOR USE STATEMENT

APRIL 00

The AngioJet XPEEDIOR Rheolytic" Thrombectomy Catheter is intended for breaking in
anart and removing thromber from A. Y apart and removing thrombus from A-V access conduits when used with the AngioJet System.

Christopher An Dillard

(Division Sign-Off) (Division Sign-Oft)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Devices Division of Carant and Neurological Devices
510(k) Number - 1993564

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).