(84 days)
Not Found
No
The document describes a mechanical thrombectomy system and catheter, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is intended for "breaking apart and removing thrombus from infrainguinal peripheral arteries" and for "control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system," which are therapeutic actions to treat a medical condition.
No
The device is described as a catheter intended for breaking apart and removing thrombus and for controlled infusion of fluids, which are therapeutic actions, not diagnostic.
No
The device description clearly states it is a "single-use component" and a "catheter," which are physical hardware components, not software.
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 infrainguinal peripheral arteries) to physically break apart and remove thrombus, and to infuse fluids. This is an in vivo procedure.
- Device Description: The description reinforces that it's a component of a system for mechanical thrombectomy removal, which is an in vivo intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside the body to provide information about a patient's health status, which is the core function of an IVD.
Therefore, the AngioJet Xpeedior 120 Catheter is a medical device used for in vivo treatment, not an IVD.
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; and/or
- with the AngioJet Power Pulse Kit for the control and selective infusion of physician . specified fluids, including thrombolytic agents, into the peripheral vascular system.
Product codes (comma separated list FDA assigned to the subject device)
QEZ, KRA
DXE, KRA
Device Description
The AngioJet Xpeedior 120 Catheter is a single-use component of the AngioJet Rheolytic Thrombectomy System. The AngioJet System is intended for mechanical throbectomy removal. The 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.
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
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)
The Xpeedior 120 Catheter is nearly the same device as identified K040013. Therefore, the testing listed in K040013 is sufficient to determine that the subject device is suitable for its intended use.
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized graphic. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
September 15, 2021
Possis Medical, Inc. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K052256
Trade/Device Name: Angiojet Xpeedior 120 Catheter 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 November 10, 2005. 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: 2021.09.15
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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 2005
Possis Medical, Inc. c/o Mr. Mark Stenoien Manager, Clinical & Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K052256
AngioJet® Xpeedior® 120 Catheter Regulation Number: 21 CFR 870.5150 and 870.1210 Regulation Name: Embolectomy Catheter and Continuous Flush Catheter Regulatory Class: Class II (Two) Product Code: DXE and KRA Dated: August 16, 2005 Received: August 18, 2005
Dear Mr. Stenoien:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
una R. vichner
A 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 Page
510(k) Number (if known): Kos 2256
Device Name: AngioJet Xpeedior 120 Catheter
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; and/or
- with the AngioJet Power Pulse Kit for the control and selective infusion of physician . specified fluids, including thrombolytic agents, into the peripheral vascular system.
Prescription Use X (Part 21 CFR 801 Subpart D)
:
AND/OR
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)
Dana R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K052266
Page 1 of 1
ﮯ
4
NOV 1 0 2005
SECTION 2. SUMMARY AND CERTIFICATION
| A. 510(k) Summary | |
|---|---|
| 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: | 16-August-2005 |
| Trade Name: - | The AngioJet Xpeedior 120 Catheter |
| Classification Name | |
| and Number: | AngioJet Xpeedior 120 Catheter is a class II device per 21 CFR |
| 870.5150 for peripheral thrombectomy and the Power Pulse Spray | |
| Ancillary Kit is a class II devices as defined by 21 CFR 870.1210 for | |
| infusion of Physician-specified fluids into the peripheral vasculature. | |
| Product Code: | AngioJet Xpeedior 120 Catheter product code is DXE and 74 KRA. |
| Predicate Device(s): | The AngioJet 120 Catheter is substantially equivalent to the devices |
| listed below: | |
| • The AngioJet Pulse Spray Kit and Xpeedior 120 Catheter | |
| (K040013.) | |
| Device Description: | The AngioJet Xpeedior 120 Catheter is a single-use component of |
| the AngioJet Rheolytic Thrombectomy System. The AngioJet | |
| System is intended for mechanical throbectomy removal. The | |
| 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. | |
| 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; and/or | |
| • with the AngioJet Power Pulse Kit for the control and selective | |
| infusion of physician specified fluids, including thrombolytic | |
| agents, into the peripheral vascular system. | |
| Functional and | |
| Safety Testing: | The Xpeedior 120 Catheter is nearly the same device as identified |
| K040013. Therefore, the testing listed in K040013 is sufficient to | |
| determine that the subject device is suitable for its intended use. | |
| Conclusion: | Possis Medical, Inc. considers the Xpeedior 120 Catheter 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. |
.