(115 days)
Not Found
No
The document describes a mechanical thrombectomy device and does not mention any AI or ML components or functionalities.
Yes
The device is intended for "breaking apart and removing thrombus from A-V access conduits," which is a direct therapeutic intervention to treat a medical condition (thrombus removal).
No
The device is described as a thrombectomy set intended for breaking apart and removing thrombus, which is a therapeutic function, not a diagnostic one. It also mentions injecting contrast media, which is typically for imaging to guide treatment, not for diagnosing a condition with the device itself.
No
The device description clearly states it is a "sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit," indicating it is a physical medical device with hardware components, 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 is to "break apart and remove thrombus from A-V access conduits." This is a therapeutic procedure performed directly on the patient's vascular system.
- Device Description: The device is a "thrombectomy set" including a catheter and pump, used with a console. It is used to physically interact with and remove material from within the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (blood, tissue, etc.) outside of the body to provide diagnostic information about a patient's condition. IVDs are primarily used for diagnosis, monitoring, or screening.
The device is clearly intended for a therapeutic intervention within the patient's body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
Product codes (comma separated list FDA assigned to the subject device)
OEZ, DXE
Device Description
Each AngioJet Ultra AVX Thrombectorny Set is a sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the vascular where the catheter is positioned.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
A-V access conduits
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)
Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra AVX Thrombectomy Set to inject contrast media and other fluids into the vascular site where the catheter is positioned.
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.
AngioJet Ultra AVX Thrombectomy Set (K073441)
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 & 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.
May 20, 2021
Possis Medical, Inc. Mark Stenoien Director Of Regulatory Affairs 9055 Evergreen Blvd., N.w. Minneapolis, Minnesota 55433-8003
Re: K082382
Trade/Device Name: AngioJet Ultra AVX Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: OEZ
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 December 12, 2008. 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: 2021.05.20
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 12 2008
Possis Medical, Inc. c/o Mr. Mark D. Stenoien Director of Regulatory Affairs 9055 Evergreen Boulevard, N.W. Coon Rapids, MN 55433
Re: K082382
AngioJet® Ultra AVX® Thrombectomy Set Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: November 20, 2008 Received: November 21, 2008
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.
11 11 11 11 11 1
2
Page 2 - Mr. Mark D. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
vuna R. Palmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
AngioJet® Ultra AVX® Thrombectomy Set
Indications For Use:
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED) . .
Nuna R. b. humen
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko82382
Possis Medical, Inc.
CONFIDENTIAL PreMarket Notification for the AngioJet Ultra AVX Thrombectomy Set Page 15 of 48
3
4
K0r23dz
DEC 1 2 2008
510(k) Summary 5.
Submitter:
Possis Medical, Inc. 9055 Evergreen Boulevard, N.W. Coon Rapids, MN 55433
Contact Person:
Mark D. Stenoien Director Regulatory Affairs Phone: 763.717.1092 Fax: 763.780.2227 Email: mark.stenoien@possis.com
| Device Common Name: | Embolectomy Catheter |
|---|---|
| Device Trade Name: | AngioJet® Ultra AVX® Thrombectomy Set |
| Device Classification Name: | Embolectomy Catheter |
| Predicate Devices: | AngioJet Ultra AVX Thrombectomy Set (K073441) |
Device Description
Each AngioJet Ultra AVX Thrombectorny Set is a sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the vascular where the catheter is positioned.
Indications for Use
The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3 mm in diameter.
Comparison to Predicate Devices
Possis Medical, Inc. considers the AngioJet Ultra AVX Thrombectomy Set 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.
Supporting Information
Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra AVX Thrombectomy Set to inject contrast media and other fluids into the vascular site where the catheter is positioned.