(11 days)
No
The summary describes a mechanical thrombectomy device and its intended use, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as being used to "break apart and remove thrombus" and for "infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system," which are actions that directly treat a medical condition (thrombus removal and drug delivery).
No
This device is designed to "break apart and remove thrombus," indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a "sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit," indicating it is a physical medical device with hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that is used within the body to break apart and remove thrombus from blood vessels. This is an in vivo procedure.
- Device Description: The description confirms it's a sterile, single-use, disposable set used with a console for a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with the body internally for treatment or removal of material.
N/A
Intended Use / Indications for Use
The AngioJet Ultra DVX Thrombectomy Set is 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 o
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of e physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Product codes
QEZ, KRA, DXE
Device Description
AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is 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
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
Bench testing was performed to support a determination of substantial equivalence to the predicate device. Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use. This included the following testing:
- Catheter operational characteristics
- Leak testing
- Guide wire compatibility tests
- Tracking
- Extended use
- Hemolysis ratio
- Distal emboli
- Catheter tip temperature
- Mechanical integrity (tensile strengths, compression / buckling, torque testing)
Key Metrics
Not Found
Predicate Device(s)
K091593 AngioJet Ultra DVX Thrombectomy Set, K101406 AngioJet Solent Proxi Thrombectomy Set
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
February 8, 2021
MEDRAD, Inc. Mike Burnside Manager 9055 Evergreen Blvd NW Minneapolis, Minnesota 55433-8003
Re: K113428
Trade/Device Name: AngioJet Ultra DVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ, KRA
Dear Mike Burnside:
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 December 02, 2011. Specifically, FDA is updating this SE Letter as an administrative correction 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. Gregory W. O'connell -S ○'connell -S Date: 2021.02.08
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 2 2011
MEDRAD. Inc. c/o Mike Burnside Manager, Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K113428
Trade/Device Name: Angiojet Ultra DVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: November 18, 2011 Received: November 21, 2011
Dear Mr. Burnside:
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. Please note: CDRH does not evaluate information related to contract liability warranties. However, we remind you that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Burnside
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); medical device reporting of medical devicerelated adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
W. H. Hillen
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
2113428 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: AngioJet® Ultra DVX® Thrombectomy Set
Indications for Use:
The AngioJet Ultra DVX Thrombectomy Set is 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 o
- for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of e physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
Prescription Use X (Part 21 CFR 801 Subpart D)
ﺮ
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Office of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K113428 |
|---|---|
| --------------- | --------- |
4
·K113428
DEC - 2 2011
:
ﭩﺮ
Section 5 – 510(k) Summary
| Submitter: | MEDRAD, Inc.
9055 Evergreen Boulevard NW
Minneapolis, MN 55433-8003 USA |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mike Burnside
Manager, Regulatory Affairs
Phone: (763) 717.1077
Fax: (763) 780.2227
Email: XXXX |
| Date Prepared: | November 18, 2011 |
| Trade Name: | AngioJet® Ultra DVX® Thrombectomy Set |
| Classification: | 870.5150 and 870.1210 |
| Product Code: | DXE and KRA |
| Predicate Device(s): | The subject device is equivalent to the following devices:
• K091593 AngioJet Ultra DVX Thrombectomy Set
• K101406 AngioJet Solent Proxi Thrombectomy Set |
| Device Description: | AngioJet Ultra DVX Thrombectomy Set is a sterile, single use,
disposable set that includes a Thrombectomy Catheter and Pump in
one combined unit. The AngioJet Ultra DVX Thrombectomy Set is
used with the AngioJet Ultra Console. |
| Intended Use: | The AngioJet Ultra DVX Thrombectomy Set is 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. |
| Comparison to
predicate: | Design changes were made to the distal section of the AngioJet Ultra
DVX device to make the device more robust to guide wire use. |
| Performance Data: | Bench testing was performed to support a determination of substantial
equivalence to the predicate device. Results from the testing provide
assurance that the proposed device conforms to the requirements for
its intended use. This included the following testing:
• Catheter operational characteristics
• Leak testing |
5
- Guide wire compatibility tests ●
- Tracking .
- Extended use .
- Hemolysis ratio .
- Distal emboli 0
- Catheter tip temperature o
- Mechanical integrity (tensile strengths, compression / . buckling, torque testing)