(1002 days)
Not Found
No
The device description focuses on mechanical and hydraulic principles (Bernoulli effect, saline jets) for thrombus removal. There is no mention of AI, ML, image processing, or data-driven decision making within the device's operation.
Yes
The device is intended for "breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries," which directly treats a medical condition (thrombotic obstructions).
No
Explanation: The device is intended for breaking apart and removing thrombotic obstructions, which describes a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components including a catheter, pump set, and drive unit, which are hardware. The thrombectomy process involves mechanical action and fluid dynamics, not solely software functions.
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 thrombotic obstructions from infra-inguinal peripheral arteries." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a mechanical system (catheter, pump set, drive unit) that physically interacts with and removes thrombus from blood vessels.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide diagnostic information. IVDs are used to perform tests on samples to diagnose conditions, monitor treatments, or screen for diseases.
The AngioJet System is a medical device used for a therapeutic intervention (thrombectomy) within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The AngioJet System, with the Catheter, is intended for breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries ≥ 2.0 mm in diameter.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, KRA, DXE
Device Description
The AngioJet Rheolytic Thrombectomy System consists of a single-use Catheter, single-use Pump Set, and multi-use Drive Unit. The same Drive Unit and Pump Set are compatible with various Catheters with different design features.
The Catheter tracks and operates over a guide wire and is introduced through a guide catheter. It may be operated only in conjunction with the Pump Set and Drive Unit. Catheter components include a manifold, shaft, and tip segments. The manifold contains connections for the high pressure saline supply and effluent removal lines on the Pump Set, and a hemostasis valve for sealing around the guide wire. The Catheter shaft is dual lumen: one lumen provides high pressure saline delivered to the Catheter tip through a stainless steel hypodermic tube; the other larger lumen is used for evacuation of thrombotic debris and for guide wire passage. The Catheter tip is a stainless steel sub-assembly through which the stainless steel hypodermic tubing extends and terminates distally in a closed loop. The loop contains proximally directed jet orifices aimed at the evacuation lumen entrance.
Thrombectomy is accomplished with the introduction of a pressurized saline jet stream through the directed orifices in the Catheter distal tip. The jets generate a localized low pressure zone via the Bernoulli effect, which entrains and macerates thrombus. The same jets also provide the dynamic pressure to drive thrombotic debris down the exhaust lumen of the Catheter and out of the body for disposal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infra-inguinal peripheral arteries
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)
A prospective non-randomized cohort study compared clinical results of patients treated with AngioJet for peripheral arterial thrombus to a similar group of patients treated with standard intra-arterial infusion of urokinase.
AngioJet treatment showed higher effectiveness in thrombus removal (complete thrombus removal not requiring additional intervention). A lower percentage of AngioJet patients reported distal embolization events requiring additional thrombectomy aspiration or local thrombolytic intervention. Any dissection or vessel perforation in the AngioJet group was minor without clinical sequelae. The AngioJet group had dramatically fewer deaths (less than 50% of the urokinase group), higher amputation-free survival, and higher primary patency at six and twelve months.
The analysis concluded no evidence of higher frequency or severity of procedure-related complications with AngioJet compared to urokinase, and that one-year follow-up data suggested no increased risk of death, amputation, or loss of patency due to AngioJet treatment.
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.
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
§ 870.5150 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2021
Possis Medical, Inc. James Gustafson V.P. Of Quality Systems And Reg./clinical Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K972610
Trade/Device Name: AngioJet Rapid Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear James Gustafson:
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 April 11, 2000. 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. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2021.10.08
10:39:45-04'00'
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/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 1 2000
Mr. James D. Gustafson Possis Medical, Inc. 9055 Evergreen Boulevard NW Minneapolis, MN 55433
K972610 Re: AngioJet® LF140 Rheolytic Thrombectomy Regulatory Class: II (two) Product Code: DXE Dated: February 28, 2000 February 29, 2000 Received:
Dear Mr. Gustafson:
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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulation 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. James D. Gustafson
Electronic Product Radiation Control provisions, or other Federal laws or This letter will allow you to begin marketing your device requlations. 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 requlation 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,
sincerely yours,
Chistopher M. Ashton
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® LF140 CATHETER INDICATION FOR USE STATEMENT
FEBRUARY 2000
The AngioJet System, with the Catheter, is intended for breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries ≥ 2.0 mm in diameter.
Christopher Ah for Dillard
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K972610
4
APR 1 1 2000
POSSIS ANGIOJET RAPID THROMBECTOMY SYSTEM 510(K) SUMMARY
SUBMITTER INFORMATION
ANCIOJET e o l y t i c " t h r o m b e c t o m y s y s t e m
| SUBMITTER NAME | Possis Medical, Inc. (PMI) |
|---|---|
| ADDRESS | 9055 Evergreen Boulevard NW |
| Minneapolis, MN 55433 | |
| PHONE NUMBER | (612) 780-4555 |
| FAX NUMBER | (612) 780-2227 |
| CONTACT | Primary |
| James D. Gustafson | |
| Vice President of Quality Systems | |
| and Regulatory/Clinical Affairs | |
| Alternate | |
| Timothy J. Kappers | |
| Supervisor, Regulatory Affairs & Compliance | |
| SUMMARY DATE | February 28, 2000 |
DEVICE NAMES
| TRADE NAME | Possis AngioJet Rapid Thrombectomy Catheter:
LF140 Catheter, Model 3040C |
|---------------------|-----------------------------------------------------------------------------|
| COMMON NAME | Embolectomy / Thrombectomy Catheter |
| CLASSIFICATION NAME | Embolectomy Catheter (21 CFR 870.5150) |
LEGALLY MARKETED
PREDICATE DEVICES
| | Fogarty Arterial Embolectomy Catheter
Baxter Healthcare Corp., Edwards U.S. Division
(Pre-1976 device)
Applied Vascular Arterial Embolectomy Catheter
Applied Vascular Devices, Inc.
K901627
Possis AngioJet Rapid Thrombectomy Catheters
Possis Medical, Inc.
K960970 |
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Summary - 1 Possis Medical, Inc. 9055 Evergreen Boulevard NW, Minneapolis, MN 55433-8003 phone: 612.780.4555 fax: 612.783.8463 toll free: 800.810.7677
Image /page/4/Picture/6 description: The image contains a logo for Possis Medical Inc. The logo features a stylized letter "M" inside a square on the left. To the right of the square is the text "POSSIS" in bold, sans-serif font, with "MEDICAL INC" written in a smaller font size below it.
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DEVICE DESCRIPTION:
The AngioJet Rheolytic Thrombectomy System consists of a single-use Catheter, single-use Pump Set, and multi-use Drive Unit. The same Drive Unit and Pump Set are compatible with various Catheters with different design features.
The Catheter tracks and operates over a guide wire and is introduced through a guide catheter. It may be operated only in conjunction with the Pump Set and Drive Unit. Catheter components include a manifold, shaft, and tip segments. The manifold contains connections for the high pressure saline supply and effluent removal lines on the Pump Set, and a hemostasis valve for sealing around the guide wire. The Catheter shaft is dual lumen: one lumen provides high pressure saline delivered to the Catheter tip through a stainless steel hypodermic tube; the other larger lumen is used for evacuation of thrombotic debris and for guide wire passage. The Catheter tip is a stainless steel sub-assembly through which the stainless steel hypodermic tubing extends and terminates distally in a closed loop. The loop contains proximally directed jet orifices aimed at the evacuation lumen entrance.
Thrombectomy is accomplished with the introduction of a pressurized saline jet stream through the directed orifices in the Catheter distal tip. The jets generate a localized low pressure zone via the Bernoulli effect, which entrains and macerates thrombus. The same jets also provide the dynamic pressure to drive thrombotic debris down the exhaust lumen of the Catheter and out of the body for disposal.
INTENDED USE:
The AngioJet System, with the Catheter, is intended for breaking apart and removing thrombotic obstructions from infra-inguinal peripheral arteries ≥ 2.0 mm in diameter.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The AngioJet LF140 Catheter is the subject of the present 510(k) and is identical to the Catheter model cleared under K960970. The AngioJet Catheter and Fogarty-type embolectomy / thrombectomy catheters share the following characteristics: both are Catheter mediated methods for mechanical thrombectomy. The diameter of the AngioJet Catheter is within the range of diameters available for the predicate device. Both the AngioJet Catheter and the predicate devices are constructed of steel and plastic materials, and are sterile, one time use class II medical devices.
The only technology difference between the AngioJet Catheter and the predicate devices is in the method that each uses to achieve mechanical thrombectomy. The Fogarty-type catheters use mechanical dislodgment and isolation to achieve thrombectomy. Using surgical introduction, the Fogarty-type device is advanced through the target lesion proximal to distal. The balloon at the distal tip is inflated with a suitable medium and the Catheter is dragged out of the vessel. The inflated
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balloon is occlusive inside the vessel lumen so the thrombus is dislodged and removed from the body through the access site.
By comparison, the AngioJet Drive Unit and Pump Set deliver a high-velocity stream of sterile saline through the hypotube to the distal tip of the Catheter. The saline exits the Catheter through holes which direct the stream of saline past a small open space and into the mouth of the exhaust lumen of the Catheter. These high-velocity saline jets create a venturi effect which produces a local area of very low pressure around the Catheter tip, which attracts thrombus into the region of high velocity jets, which in turn disassociate the thrombus into small particles and propel the debris down the effluent lumen of Catheter and out of the patient's body. The AngioJet Catheter is introduced percutaneously and advanced over a guidewire to the target lesion. The Catheter may be operated in the target vessel proximal to distal or distal to proximal.
SUMMARY OF CLINICAL RESULTS
The AngioJet LF140 Catheter has already been proven safe and effective in the treatment of patients with coronary thrombus. For peripheral arterial thrombus, an analysis was performed comparing clinical results from a prospective non-randomized cohort of patients treated with AngioJet for peripheral arterial thrombus to clinical results reported in the literature for a similar group of patients treated with standard intra-arterial infusion of urokinase.
AngioJet treatment resulted in a higher reported effectiveness for its primary function of thrombus removal (complete thrombus removal not requiring additional intervention to treat thrombus). A lower percentage of patients using AngioJet reported distal embolization events requiring additional thrombectomy aspiration or local thrombolytic intervention. Any dissection or vessel perforation that occurred in the AngioJet group was minor, without clinical sequelae.
The AngioJet study group also had dramatically fewer deaths (less than 50% of that reported for the urokinase group), higher amputation-free survival, and higher primary patency than the urokinase group, at both six and twelve month follow-up.
The analysis concluded that there was no evidence to suggest that either the frequency or severity of procedure-related complications were higher with use of AngioJet than with urokinase, and that one-year follow-up data suggests no increased risk of death, amputation, or loss of patency due to AngioJet treatment over that seen in patients treated with urokinase.
The results from this comparison are sufficient evidence to support an expansion of the indication for use of the AngioJet LF140 Catheter to include the treatment of thrombus in peripheral arteries and arterial conduits.