(134 days)
Not Found
No
The description focuses on mechanical and fluid dynamics principles for thrombus removal and fluid infusion, with no mention of AI or ML technologies.
Yes
The device is intended for "breaking apart and removing thrombus from infrainguinal peripheral arteries" and "control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system," which are therapeutic actions.
No
The device is intended for breaking apart and removing thrombus, and for controlled infusion of fluids, which are therapeutic actions rather than diagnostic ones.
No
The device description clearly outlines physical components like catheters, tubing, and a Y-set, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) to break apart and remove thrombus from arteries and to infuse fluids into the peripheral vascular system. IVDs are used to examine specimens from the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter and ancillary kit designed for insertion into blood vessels and interaction with the circulatory system. This is consistent with an in vivo medical device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or laboratory procedures typically associated with IVD devices.
Therefore, the AngioJet Xpeedior 120 Catheter and AngioJet Power Pulse Spray Ancillary Kit are medical devices intended for therapeutic and interventional use within the body, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
- 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.
Product codes (comma separated list FDA assigned to the subject device)
DXE, KRA, QEZ
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 Xpeedior 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.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infrainguinal peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
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.
K972610, K993564, K905447, K951509, K780551
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). 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.
-
- 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
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SUMMARY AND CERTIFICATION SECTION 2.
| 510(k) Summary
| A. | ||
|---|---|---|
| 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 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.) | ||
| Intended Use: | 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. | ||
| Functional and | ||
| Safety 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 and | ||
| effectiveness and to demonstrate appropriate functional and | ||
| performance characteristics. | ||
| Conclusion: | Possis Medical, Inc. considers the Xpeedior 120 Catheter and the | |
| Power Pulse Spray Ancillary Kit to be substantially equivalent to the | ||
| predicate devices listed above. This conclusion is based upon the | ||
| devices' similarities in functional design, materials, indications for | ||
| use and principles of operation. |
5