(20 days)
No
The document describes a mechanical thrombectomy device and does not mention any AI or ML components or functionalities.
Yes
The device is intended to break apart and remove thrombus from the vascular system, which is a therapeutic intervention.
No
The device is described as an AngioJet Ultra DVX and Xpeedior Thrombectomy Set, which is used to break apart and remove thrombus (blood clots), and for the infusion of fluids. These are therapeutic actions, not diagnostic ones.
No
The device description explicitly states that the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are "sterile, single use, disposable sets that include a Thrombectomy Catheter and Pump in one combined unit." This indicates the device is a physical, hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed within the body (in vivo) to remove thrombus from blood vessels. IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The device is a thrombectomy set, which is a surgical tool used for mechanical removal of blood clots. This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are medical devices used for a therapeutic procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the Angiojet Ultra Console to break apart and remove thrombus from:
- upper and lower extremity peripheral arteries ≥ 3.0mm in diameter,
- upper extremity peripheral veins ≥ 3.0mm in diameter,
- ileofemoral and lower extremity veins ≥ 3.0mm in diameter,
- A-V access conduits ≥ 3.0mm in diameter and
- for use with the Angiojet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Product codes
DXE, KRA
Device Description
AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremity peripheral arteries, upper extremity peripheral veins, ileofemoral and lower extremity veins, A-V access conduits
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Functional and Safety Testing: Representative samples of the device underwent mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071342, K090253, K072269, K090253
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Section 5 – 510(k) Summary
:
| Submitter: | MEDRAD Interventional / Possis
9055 Evergreen Boulevard NW
Minneapolis, MN 55433-8003 USA |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Doug Atkins
Sr. Regulatory Affairs Associate
Phone: (763) 450-8060
Fax: (763) 780-2227
Email: doug.atkins@possis.com |
| | JUN 22 2009 |
| Date Prepared: | May 29, 2009 |
| Trade Name: | AngioJet® Ultra DVX® Thrombectomy Set
AngioJet® Ultra Xpeedior® Thrombectomy Set |
| Classification: | 870.5150 and 870.1210 |
| Product Code: | DXE and KRA |
| Predicate Device(s): | The subject devices are equivalent to the following devices:
K071342 and K090253 AngioJet Ultra Xpeedior Thrombectomy SetK072269 and K090253 AngioJet Ultra DVX Thrombectomy Set |
| Device Description: | AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the Angiojet Ultra Console to break apart and remove thrombus from:
upper and lower extremity peripheral arteries ≥ 3.0mm in diameter,upper extremity peripheral veins ≥ 3.0mm in diameter,ileofemoral and lower extremity veins ≥ 3.0mm in diameter,A-V access conduits ≥ 3.0mm in diameter andfor use with the Angiojet Ultra 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: | Representative samples of the device underwent mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics. |
| Conclusion: | MEDRAD Interventional / Possis considers the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets 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. |