(190 days)
AngioJet LF140 Catheter
Not Found
No
The device description focuses on mechanical and fluid dynamics principles for thrombus removal. There is no mention of AI, ML, or any computational processing of data for decision-making or optimization.
Yes.
The device is intended for "breaking apart and removing thrombus" from human A-V access conduits, which is a direct treatment of a medical condition (thrombus).
No
The device's intended use is to "break apart and remove thrombus," which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter body, manifold, and tip, and describes a mechanical process involving saline jets and thrombus removal. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "break apart and remove thrombus from A-V access conduits." This is a therapeutic procedure performed directly on the patient's body (in vivo).
- Device Description: The description details a mechanical device that physically interacts with and removes material from within the body. It involves high-pressure saline jets and a vacuum effect to break down and remove thrombus.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The AngioJet XPEEDIOR Rheolytic Thrombectomy Catheter is a therapeutic medical device used for a procedure performed within the patient's vascular system.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MCW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
A-V access conduits
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AngioJet LF140 Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
APR 2 8 2000
ANGIOJET® XPEEDIOR™ CATHETER 510(K) SUMMARY
APRIL 2000
| SUBMITTER'S
INFORMATION | Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433
Tel: (612) 780-4555
Fax: (612) 780-2227 | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--|
| CONTACT | Primary | |
| | Timothy J. Kappers
Supervisor, Regulatory Affairs & Compliance | |
| | Alternate | |
| | James D. Gustafson
Vice President of Quality Systems
and Regulatory/Clinical Affairs | |
| SUMMARY DATE | April 18, 2000 | |
| DEVICE TRADE NAME | AngioJet XPEEDIOR Catheter | |
| COMMON NAME | Thrombetomy/Embolectomy Catheter | |
| DEVICE CLASS | Class II | |
| LEGALLY MARKETED
PREDICATE DEVICE | AngioJet LF140 Catheter | |
1
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.
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.
2
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 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 |
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.
3
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.
4
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
5
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